Device manufacturer, as written on reports

Roche Diabetes Care: medical device reports filed with FDA

51,667 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.

51,667
reports naming it as manufacturer: 0.2% of all MAUDE reports; 872
reports, 12 months to August 2026: 1,663 in the 12 months before; 94.3%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

51,667 medical device reports received by FDA give Roche Diabetes Care as the manufacturer of the device involved, 0.2% of the MAUDE database, from February 2013 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

872 reports arrived in the 12 months to August 2026, down 48% from 1,663 in 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 (94.3%) and injury (5.7%). 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
Accu-Chek Spirit Combo	Pump, infusion, insulin	16,799	0	0.1%
Accu-Chek Aviva Plus Test Strips	Glucose dehydrogenase, glucose	4,992	0	0%
Accu-Chek Performa Test Strips	System, test, blood glucose, over the counter	2,857	1	0%
Accu-Chek Aviva Combo	System, test, blood glucose, over the counter	2,212	2	0%
Accu-Chek Guide Test Strips	System, test, blood glucose, over the counter	2,195	0	0%
Accu-Chek Performa Combo	System, test, blood glucose, over the counter	1,911	42	0%
Accu-Chek Aviva Test Strips	Glucose dehydrogenase, glucose	1,820	0	0%
Accu-Chek Insight Pump	Pump, infusion, insulin	1,802	0	0.1%
Accu-Chek Insight Flex	Set, administration, intravascular	1,683	0	0%
Accu-Chek Flexlink Infusion Set	Set, administration, intravascular	1,512	0	0%
Accu-Chek 3 15 Ml Insulin Cartridge	Pump, infusion, insulin	1,295	0	0%
Softclix Lancet Device	Single use only blood lancet with an integral sharps injury prevention feature	1,190	80	0%
Accu-Chek Fastclix	Single use only blood lancet with an integral sharps injury prevention feature	890	56	0%
Accu-Chek Multiclix	Single use only blood lancet with an integral sharps injury prevention feature	880	0	0%
Accu-Chek Guide	Glucose dehydrogenase, glucose	772	365	0%
Accu-Chek Spirit	Pump, infusion, insulin	771	0	0.3%
Accu-Chek Smartview Test Strips	Glucose dehydrogenase, glucose	610	0	0%
Accu-Chek Mobile Test Strips	Glucose dehydrogenase, glucose	571	0	0%
Accu-Chek Compact Test Drum	Glucose dehydrogenase, glucose	521	0	0%
Accu-Chek Flexlink Plus Infusion Set	Set, administration, intravascular	515	0	0.1%
Accu-Chek Active Test Strips	Glucose dehydrogenase, glucose	447	0	0%
Accu-Chek Compact Plus Test Drum	Glucose dehydrogenase, glucose	421	0	0%
Accu-Chek Instant Test Strips	Glucose oxidase, glucose	415	0	0%
Accu-Chek Ultraflex Infusion Set	Set, administration, intravascular	410	0	0%
Accu-Chek Instant	Glucose dehydrogenase, glucose	368	183	0%
Accu-Chek Rapid-D Infusion Set	Set, administration, intravascular	346	0	0%
Accu-Chek Insight Flexlink Plus Infusion Set	Set, administration, intravascular	327	0	0%
Accu-Chek Linkassist	Introducer, syringe needle	300	0	0%
Accu-Chek Insight Meter	System, test, blood glucose, over the counter	298	0	0%
Accu-Chek Aviva Expert	System, test, blood glucose, over the counter	225	0	0%

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
LZG	Pump, infusion, insulin	20,928	40.5%
NBW	System, test, blood glucose, over the counter	15,973	30.9%
FPA	Set, administration, intravascular	5,721	11.1%
LFR	Glucose dehydrogenase, glucose	5,088	9.8%
FMK	Single use only blood lancet with an integral sharps injury prevention feature	2,994	5.8%
KZH	Introducer, syringe needle	498	1%
CGA	Glucose oxidase, glucose	457	0.9%
NDC	Calculator, drug dose	75	0.1%
OZP	Automated insulin dosing device system, single hormonal control	7	0%
JJX	Single (specified) analyte controls (assayed and unassayed)	5	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%7

Injury5.7%2,937

Malfunction94.3%48,716

Other0%3

Not given0%4

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

Questions about Roche Diabetes Care reports

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

51,667 reports through August 2026, 872 of them in the latest 12 months.

Which of its brands appear most often?

Accu-Chek Spirit Combo (16,799), Accu-Chek Aviva Plus Test Strips (4,992), Accu-Chek Performa Test Strips (2,857), Accu-Chek Aviva Combo (2,212) and Accu-Chek Guide Test Strips (2,195).

Which device types does it report on?

pump, infusion, insulin (40.5%), system, test, blood glucose, over the counter (30.9%), set, administration, intravascular (11.1%) and glucose dehydrogenase, glucose (9.8%).

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.