Device manufacturer, as written on reports

Tandem Diabetes Care: medical device reports filed with FDA

1,373,250 reports name it as the manufacturer of the device involved, 2013–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

1,373,250
reports naming it as manufacturer: 5.3% of all MAUDE reports; 244,646
reports, 12 months to August 2026: 246,982 in the 12 months before; 88%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

1,373,250 medical device reports received by FDA give Tandem Diabetes Care as the manufacturer of the device involved, 5.3% of the MAUDE database, from May 2013 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

244,646 reports arrived in the 12 months to August 2026, close to the 246,982 of the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (88%) and injury (11.9%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
t:slim X2 Insulin Pump with Control-IQ Technology	Alternate controller enabled insulin infusion pump	584,122	129,119	0%
t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)	Alternate controller enabled insulin infusion pump	267,629	11,502	0%
t:slim X2 Insulin Pump with Basal-IQ Technology	Automated insulin dosing , threshold suspend	142,635	1,916	0%
t:slim X2 Insulin Pump with Control-IQ+ Technology	Alternate controller enabled insulin infusion pump	65,297	57,936	0%
Tandem T Slim Insulin Delivery System	Pump, infusion, insulin	52,251	0	0.1%
t:slim X2 Insulin Pump with Interoperable Technology	Alternate controller enabled insulin infusion pump	37,128	865	0%
Tandem Mobi Insulin Pump with Control-IQ+ Technology	Alternate controller enabled insulin infusion pump	36,499	31,674	0%
T Slim G5 System	Pump, infusion, insulin, to be used with invasive glucose sensor	36,250	0	0%
t:slim G4 system	Pump, infusion, insulin, to be used with invasive glucose sensor	35,415	20	0%
t:slim X2 Insulin Pump	Pump, infusion, insulin	31,147	86	0%
Tandem Mobi Insulin Pump with Interoperable Technology	Alternate controller enabled insulin infusion pump	27,951	1,595	0%
t:slim Insulin Delivery System	Pump, infusion, insulin	19,276	30	0.1%
Tandem Mobi Insulin Pump with Control-IQ Technology	Alternate controller enabled insulin infusion pump	15,153	9,553	0%
T Flex Insulin Delivery System	Pump, infusion, insulin	11,220	0	0.1%
T Slim X2 Basal-Iq Mmol/L	Automated insulin dosing , threshold suspend	3,120	0	0%
T Slim X2 Insulin Pump With Interoperable Technology With T Connect Mobile A	Alternate controller enabled insulin infusion pump	2,555	0	0%
Tandem T Flex Insulin Delivery System	Pump, infusion, insulin	528	0	0.2%
T Slim X2 Basal Iq Mg/Dl	Automated insulin dosing , threshold suspend	477	0	0%
T Slim X2 Insulin Pump With Interoperable Technology With T Connect Mobile Ap	Alternate controller enabled insulin infusion pump	453	0	0%
Tandem Mobi Mobile App	Alternate controller enabled insulin infusion pump	443	340	0%
T Slim X2 Basal-Iq Mg/Dl	Automated insulin dosing , threshold suspend	435	0	0%
T Slim X2 With Basal-Iq Technology	Alternate controller enabled insulin infusion pump	414	0	0%
T Slim X2 Insulin Pump With Control-Iq Technology With T Connect Mobile App	Alternate controller enabled insulin infusion pump	296	0	0%
Tandem T Slim Insulin Delivery Sys	Pump, infusion, insulin	286	0	0%
Tandem T Slim Insulin Deliver System	Pump, infusion, insulin	273	0	0%
T Slim X2 Insulin Pump With Interoperable Technology With T Connect Mobi	Alternate controller enabled insulin infusion pump	184	0	0%
Dexcom G6 Continuous Glucose Monitoring System	Integrated continuous glucose monitoring system, factory calibrated	43	61,710	0%
Autosoft Xc	Set, administration, intravascular	1	49	0%
Cartridge	Set, tubing, blood, with and without anti-regurgitation valve	1	0	3%
Infusion Pump	Pump, infusion, implanted, programmable	1	6	3.7%

Brands with a page on this site, ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Device types

Product code	Device type	Reports	Share
QFG	Alternate controller enabled insulin infusion pump	1,042,455	75.9%
OZO	Automated insulin dosing , threshold suspend	143,707	10.5%
LZG	Pump, infusion, insulin	103,231	7.5%
OYC	Pump, infusion, insulin, to be used with invasive glucose sensor	84,320	6.1%
QBJ	Integrated continuous glucose monitoring system, factory calibrated	75	0%
PQF	Sensor, glucose, invasive, non-adjunctive	20	0%
QJI	Interoperable automated glycemic controller	7	0%
FPA	Set, administration, intravascular	5	0%
FRN	Pump, infusion	5	0%
OUG	Medical device data system	3	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type

Death0%312

Injury11.9%164,012

Malfunction88%1,208,913

Other0%6

Not given0%7

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Tandem Diabetes Care reports

How many FDA device reports name Tandem Diabetes Care as manufacturer?

1,373,250 reports through August 2026, 244,646 of them in the latest 12 months.

Which of its brands appear most often?

t:slim X2 Insulin Pump with Control-IQ Technology (584,122), t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) (267,629), t:slim X2 Insulin Pump with Basal-IQ Technology (142,635), t:slim X2 Insulin Pump with Control-IQ+ Technology (65,297) and Tandem T Slim Insulin Delivery System (52,251).

Which device types does it report on?

alternate controller enabled insulin infusion pump (75.9%), automated insulin dosing , threshold suspend (10.5%), pump, infusion, insulin (7.5%) and pump, infusion, insulin, to be used with invasive glucose sensor (6.1%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.