Reported Reactions

Devices › Pump, infusion, insulin

Device brand name · Insulin infusion pump accessory

Accu-Chek 3 15 Ml Insulin Cartridge: medical device reports filed with FDA

1,474 reports name it, 2013–2024. Manufacturer given most often on reports: Roche Diabetes Care. Product code LZG.

1,474
device reports naming the brand
0% of all MAUDE reports · about 111 a year
0
reports, 12 months to August 2026
0 in the 12 months before
94%
classified as malfunction
81.6% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 1,474 reports that name the brand "Accu-Chek 3 15 Ml Insulin Cartridge" (insulin infusion pump accessory), received between April 2013 and August 2024; the manufacturer given most often on reports is Roche Diabetes Care. Spellings of one product vary from report to report.

0 reports arrived in the 12 months to August 2026, and none 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%) and injury (6%); across all pump, infusion, insulin reports (product code LZG) death is recorded in 0.3% and malfunction in 81.6%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are fluid/blood leak (49.5%), leak/splash (47.5%) and insufficient device problem information (1%). The patient problems coded most often are hyperglycemia, elevated ketones/ diabetic ketoacidosis and hypoglycemia. 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."

Reports by month, five years

0918Sep 2021: 7Oct 2021: 13Nov 2021: 8Dec 2021: 92022Jan 2022: 5Feb 2022: 7Mar 2022: 5Apr 2022: 8May 2022: 6Jun 2022: 9Jul 2022: 13Aug 2022: 10Sep 2022: 8Oct 2022: 15Nov 2022: 14Dec 2022: 92023Jan 2023: 7Feb 2023: 4Mar 2023: 6Apr 2023: 9May 2023: 10Jun 2023: 8Jul 2023: 10Aug 2023: 8Sep 2023: 6Oct 2023: 9Nov 2023: 7Dec 2023: 62024Jan 2024: 3Feb 2024: 5Mar 2024: 6Apr 2024: 11May 2024: 3Jun 2024: 5Jul 2024: 18Aug 2024: 4Sep 2024: 0Oct 2024: 0Nov 2024: 0Dec 2024: 02025Jan 2025: 0Feb 2025: 0Mar 2025: 0Apr 2025: 0May 2025: 0Jun 2025: 0Jul 2025: 0Aug 2025: 0Sep 2025: 0Oct 2025: 0Nov 2025: 0Dec 2025: 02026Jan 2026: 0Feb 2026: 0Mar 2026: 0Apr 2026: 0May 2026: 0Jun 2026: 0Jul 2026: 0Aug 2026: 0

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

By year received

0901792013: 3220132014: 942015: 17120152016: 1792017: 16520172018: 1512019: 17020192020: 1552021: 10320212022: 1092023: 9020232024: 55

Event type and report source

Event type, as classified on the report

Death0%0
Injury6%88
Malfunction94%1,386
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%1,474
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 539,975 reports carrying product code LZG. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Fluid/blood leak72949.5%2.2%
Leak/splashthe device leaked70047.5%0.7%
Insufficient device problem information151%5%
Defective devicethe device was defective90.6%0.1%
Infusion or flow problema problem with flow or infusion70.5%0.2%
Pumping problem60.4%0.1%
Crackthe device cracked30.2%3.8%
Detachment of device or device componentpart of the device came off30.2%0.2%
Air leak20.1%0.3%
Insufficient flow or under infusion20.1%0.3%
Air/gas in device10.1%0%
Breakthe device broke10.1%2.9%
Defective component10.1%0.1%
Device handling problem10.1%0%
Explosion10.1%0%
Impedance problem10.1%0%
Improper or incorrect procedure or method10.1%1.1%
Moisture or humidity problem10.1%0.5%
Occlusion within devicethe device blocked10.1%1.8%
Unexpected therapeutic results10.1%0%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)ReportsShare
Hyperglycemiahigh blood sugar41728.3%
Elevated ketones/ diabetic ketoacidosis332.2%
Hypoglycemialow blood sugar90.6%
Vomitingbeing sick30.2%
Headachehead pain20.1%
Coma10.1%
Diarrhea10.1%
Fatiguetiredness10.1%
Nauseafeeling sick10.1%
Therapeutic effects, unexpected10.1%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureAccu-Chek 3 15 Ml Insulin CartridgeProduct code LZGAll MAUDE reports
Reports1,474539,97526,136,888
Share of that pool—0.3%0%
Classified as death, per 1,000 reports039
Classified as injury6%17.8%36.2%
Classified as malfunction94%81.6%62.3%
Filed by the manufacturer100%99.8%94.9%

Shares are of reports, not 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."

Other brands with product code LZG

BrandReportsLatest 12 monthsClassified as death
Onetouchping Glucosemgmtsystem98,94500.1%
Omnipod DASH Insulin Management System62,6465,5630.1%
Tandem T Slim Insulin Delivery System55,20700.1%
OmniPod Insulin Pump45,2721450.3%
Omnipod Insulin Management System37,5822180.1%
Animas Vibe88,70300%
Animas Insulin Infusion Pump26,29300.3%
MMT-712 PARADIGM Insulin Pump25,7814,1380%
Accu-Chek Spirit Combo21,25200.1%
t:slim Insulin Delivery System19,277300.1%
t:slim X2 Insulin Pump31,159860%
Animas Insulin Cartridge12,10500%
T Flex Insulin Delivery System11,35900.1%
Paradigm Insulin Infusion Pump16,32400.4%
Accu-Chek Spirit8,82600.3%

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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about Accu-Chek 3 15 Ml Insulin Cartridge reports

How many FDA reports name Accu-Chek 3 15 Ml Insulin Cartridge?

1,474 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

malfunction (94%) and injury (6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

fluid/blood leak (49.5%), leak/splash (47.5%), insufficient device problem information (1%), defective device (0.6%) and infusion or flow problem (0.5%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Accu-Chek 3 15 Ml Insulin Cartridge was at fault?

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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.