ACCU-CHEK AVIVA PLUS 06908152001Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00365702405103), received between Oct 24, 2019 and Sep 2, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 285 MG/DL, 118 MG/DL, 121 MG/DL, AND 126 MG/DL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10481141 ↗
• MalfunctionDec 18, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 10 MINUTES: 148 MG/DL (AVIVA) AND 300 MG/DL (COMPACT).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9489262 ↗
• MalfunctionOct 24, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 10 MINUTES: 500 MG/DL AND 117 MG/DL. IT IS UNKNOWN WHICH TEST STRIP LOT NUMBER WAS USED FOR THE RESULT COMPARISON. AN UNKNOWN TEST STRIP LOT NUMBER OR LOT NUMBER (498310) COULD HAVE BEEN USED FOR THE RESULT COMPARISON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9234580 ↗