ACCU-CHEK AVIVA EXPERT 05075637005Recalls & reported problems
Roche Diagnostics Operations, Inc. · ACCU-CHEK AVIVA EXPERT MG/DL (650) · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00365702641105), received between Sep 6, 2019 and Mar 15, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Application Program Problem: Dose Calculation Error” (3 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.
Reports received per month
Most reported problems
Device problems
- Application Program Problem: Dose Calculation Error3
Patient problems
- No Consequences Or Impact To Patient2
- Dizziness1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 15, 2024Application 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. THE PATIENT RECEIVED AN ESTIMATED BLOOD GLUCOSE RESULT OF 170 MG/DL AROUND 6:30 A.M. AND THE BOLUS RECOMMENDATION WAS 2.5 UNITS OF INSULIN BASED ON THE BLOOD GLUCOSE RESULT. THE PATIENT THOUGHT THE RECOMMENDATION WAS TOO MUCH, BUT SHE DELIVERED 3 UNITS OF HUMALOG INJECTION. THE PATIENT STARTED TO EXPERIENCE SYMPTOMS OF DISORIENTATION ASSOCIATED WITH LOW BLOOD GLUCOSE. SHE WAS ABLE TO CONSUME FOOD AND DRINK ON HER OWN TO INCREASE THE BLOOD GLUCOSE LEVEL WITHOUT OUTSIDE ASSISTANCE. THE PATIENT BELIEVED A 2.0 UNITS RECOMMENDATION WOULD HAVE BEEN APPROPRIATE ON THE BLOOD GLUCOSE MONITOR.
Patient problems: Dizziness
MAUDE report 18915399 ↗MalfunctionNov 20, 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 9348832 ↗MalfunctionSep 6, 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 8970084 ↗
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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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