ACCU-CHEK AVIVA COMBO 05075645005Recalls & reported problems
Roche Diagnostics Operations, Inc. · ACCU-CHEK AVIVA COMBO MG/DL (670) · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00365702647107), received between Nov 22, 2019 and May 12, 2021 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Application Program Problem: Dose Calculation Error” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Application Program Problem: Dose Calculation Error2
- Display Difficult to Read2
- Melted1
Patient problems
- No Consequences Or Impact To Patient3
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 12, 2021Display Difficult to Read; Display Difficult to Read
IT WAS REPORTED THAT THE DISPLAY OF THE BLOOD GLUCOSE MONITOR WAS DEFECTIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11811032 ↗MalfunctionSep 4, 2020Melted; Melted
IT WAS REPORTED THAT THE FRONT OF THE BLOOD GLUCOSE MONITOR APPEARED TO HAVE MELTED. NO ONE WAS INJURED BY THE DAMAGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10493218 ↗MalfunctionDec 16, 2019Display Difficult to Read; Display Difficult to Read
IT WAS REPORTED THAT THE DISPLAY OF THE BLOOD GLUCOSE MONITOR WAS DEFECTIVE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9473282 ↗MalfunctionNov 25, 2019Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error
IT WAS REPORTED THAT THE BOLUS RECOMMENDATIONS PROVIDED BY THE BLOOD GLUCOSE MONITOR ARE NOT ACCURATE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9369823 ↗MalfunctionNov 22, 2019Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error
IT WAS REPORTED THAT THE BOLUS RECOMMENDATIONS PROVIDED BY THE BLOOD GLUCOSE MONITOR ARE NOT ACCURATE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9363249 ↗
Other Pump, Infusion, Insulin devices
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- Omnipod ZXP420Insulet Corporation · Pump, Infusion, Insulin1 recall17 deaths37,832 reports
- Omnipod ZXP420Insulet Corporation · Pump, Infusion, Insulin70 deaths20,092 reports
- t:slim X2 Insulin Pump 1000103Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin1 recall1 death7,327 reports
- t:slim Insulin Pump, Reconditioned Replacement 007262Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin2 deaths5,253 reports
- t:flex Insulin Pump, Replacement, Refurbished 007473Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin2 deaths2,373 reports
- t:slim Insulin Pump 007435Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin7 deaths2,104 reports
- Accu-Chek Combo 05027250001Roche Diabetes Care GmbH · Pump, Infusion, Insulin1,830 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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