Pump, infusion, insulin, to be used with invasive glucose sensor: medical device reports filed with FDA

891,173 reports carry this product code, 2004–2026; 30 brands with a page.

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.

891,173
reports with this product code: 3.4% of all MAUDE reports; 10,637
reports, 12 months to August 2026: 13,530 in the 12 months before; 85.5%
classified as malfunction: 62.3% across all reports; 0.3%
classified as death, as reported: 0.9% across all reports

Product code OYC is FDA's classification for "Pump, infusion, insulin, to be used with invasive glucose sensor" (unknown panel), a class 3 device. 891,173 medical device reports carry this product code, 3.4% of the MAUDE database, from June 2004 to August 2026.

10,637 reports arrived in the 12 months to August 2026, down 21% from 13,530 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 (85.5%), injury (14.2%) and death (0.3%). 30 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Paradigm Real-Time Revel Insulin Infusion Pump	176,410	0	0.6%	64%
Paradigm Real-Time Insulin Infusion Pump	121,508	0	0.3%	87.9%
640G Insulin Pump MMT-1712K	119,545	1,598	0.1%	99.3%
640G Insulin Pump MMT-1711K	76,608	151	0.1%	98.8%
Animas Vibe	54,674	0	0%	98%
T Slim G5 System	49,779	0	0%	91%
t:slim G4 system	39,197	20	0%	76.8%
Pump Mmt-1712kl 640g V4 10 Bk Sf Mg	21,531	952	0%	99.1%
640g Insulin Pump	16,885	0	0%	99.6%
Paradigm REAL-Time REVEL Insulin Infusion Pump MMT-723LNAS	12,936	41	0.8%	64.9%
t:slim X2 Insulin Pump	12,459	86	0%	81.9%
Pump Mmt-1711kl 640g V4 10 Bk Sf Mm	11,157	168	0%	98.7%
Paradigm REAL-Time Insulin Infusion Pump MMT-754WWS	10,465	661	0%	98.5%
Paradigm Real-Time Revel Insulin Infusion Pump Mmt-723nas	8,523	49	0.8%	72.7%
640g Insulin Pump Mmt-1712b	5,629	1	0%	99%
Paradigm Insulin Infusion Pump	5,073	0	0.4%	89.4%
530g Insulin Pump	4,939	0	0.8%	51.6%
MiniMed 740G OUS System BLE Connect 3.0 mg/dL	4,928	1,740	0%	99.3%
640g Insulin Pump Mmt-1712w	4,788	2	0.1%	99.2%
Insulin Infusion Pump	4,639	0	2.6%	43.9%
640g Insulin Pump Mmt-1711b	4,638	1	0.1%	98.3%
Paradigm Real-Time Revel Insulin Infusion Pump Mmt-723rnas	3,985	14	1.7%	61.4%
Paradigm REAL-Time Insulin Infusion Pump MMT-754LWWS	3,797	71	0%	98.1%
630g Insulin Pump	3,609	0	0.2%	37.2%
640g Insulin Pump Mmt-1711w	3,580	2	0%	98.3%
MiniMed 720G OUS BLE Connect 3.0 mgdl	3,547	1,447	0%	98.9%
640g Insulin Pump Mmt-1712p 640g 3ml Purple Mg	3,222	0	0%	99%
640g Insulin Pump Mmt-1711p	3,114	0	0%	98.4%
Animas Vibe System	3,086	0	0.1%	98.1%
Paradigm REAL-Time REVEL Insulin Infusion Pump MMT-723NAB	2,830	9	0.8%	70.7%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Medtronic Puerto Rico Operations	598,106	67.1%
Medtronic Minimed	126,793	14.2%
Tandem Diabetes Care	84,320	9.5%
Animas	52,980	5.9%
Dexcom	22,900	2.6%
Medtronic-Chengdu	2,758	0.3%
Medtronic Puerto Rico Operations Juncos	220	0%
Medtronic Puerto Rico Operations Med-Rel	109	0%
Insulet	5	0%
Minimed	3	0%
Companion Medical	1	0%
Lake Region Medical	1	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 and report source

Event type

Death0.3%2,249

Injury14.2%126,555

Malfunction85.5%761,882

Other0%17

Not given0.1%470

Who filed

Manufacturer report100%891,055

Voluntary report0%115

User facility report0%0

Distributor report0%0

Not given0%3

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Device displays incorrect message	214,095	24%
Breakthe device broke	89,863	10.1%
Patient device interaction problem	70,661	7.9%
No display/image	44,410	5%
Power problem	43,288	4.9%
Device operates differently than expectedthe device behaved unexpectedly	40,083	4.5%
Mechanical problema mechanical problem	33,241	3.7%
Battery problema problem with the battery	27,352	3.1%
Obstruction of flow	26,599	3%
Device difficult to program or calibrate	24,942	2.8%
Device inoperablethe device could not be used	24,256	2.7%
Material integrity problema problem with the device material	23,913	2.7%
Structural problem	23,345	2.6%
Device alarm system	21,705	2.4%
Crackthe device cracked	19,375	2.2%
Insufficient device problem information	18,906	2.1%
Pumping stopped	18,724	2.1%
Moisture or humidity problem	15,289	1.7%
Connection problema connection problem	14,154	1.6%
Moisture damage	13,278	1.5%

Questions about pump, infusion, insulin, to be used with invasive glucose sensor reports

What is product code OYC?

FDA's classification code for "Pump, infusion, insulin, to be used with invasive glucose sensor", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

891,173 reports through August 2026, 10,637 of them in the latest 12 months.

Which brands appear most often?

Paradigm Real-Time Revel Insulin Infusion Pump (176,410), Paradigm Real-Time Insulin Infusion Pump (121,508), 640G Insulin Pump MMT-1712K (119,545), 640G Insulin Pump MMT-1711K (76,608) and Animas Vibe (54,674). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

No. 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 differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.