ACCU-CHEK AVIVA PLUS 06908373001Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00365702436107), received between Sep 27, 2019 and Jun 6, 2025 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (18 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2025High Test Results; High Test Results

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 186 MG/DL AT 8:16 AM (GUIDE SYSTEM). 84 MG/DL AT 8:15 AM (AVIVA SYSTEM).

  Patient problems: Dizziness

  MAUDE report 22156476 ↗
• MalfunctionMar 18, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 457 MG/DL, 200 MG/DL, AND 150 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21632438 ↗
• MalfunctionMay 10, 2024Incorrect, 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: 371 MG/DL, 181 MG/DL, AND 216 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19286438 ↗
• MalfunctionApr 16, 2024Incorrect, 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: 129 MG/DL WITH THE AVIVA METER (SYSTEM 1) AND HI (= HIGHER THAN THE MEASUREMENT RANGE OF THE METER) WITH THE GUIDE METER (SYSTEM 2).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19114184 ↗
• MalfunctionJan 9, 2024Incorrect, 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: 77 MG/DL (SYSTEM 1) AND 480 MG/DL (SYSTEM 2).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18479507 ↗
• MalfunctionJan 5, 2024Incorrect, 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: "HI" MG/DL (GREATER THAN 600 MG/DL; SYSTEM 1), "HI" MG/DL (GREATER THAN 600 MG/DL; SYSTEM 1), 493 MG/DL (SYSTEM 1), AND 111 MG/DL (SYSTEM 2). THE PATIENT USED TWO TEST STRIP VIALS FOR THE RESULT COMPARISON. THE LOT NUMBER FOR ONE TEST STRIP VIAL WAS (690483). THE LOT NUMBER FOR THE 2ND TEST STRIP VIAL WAS UNKNOWN. IT IS UNKNOWN WHICH TEST STRIP VIAL WAS USED FOR WHICH METER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18455936 ↗
• MalfunctionDec 21, 2023Incorrect, 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: 225 MG/DL AND 110 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18378479 ↗
• MalfunctionAug 30, 2023Incorrect, 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: 95 MG/DL AND 168 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17648789 ↗
• MalfunctionApr 24, 2023Incorrect, 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: 500 MG/DL, "HI" MG/DL (GREATER THAN 600 MG/DL), AND 116 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16797035 ↗
• MalfunctionApr 28, 2022Incorrect, 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: 197 MG/DL AND 423 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14240795 ↗
• MalfunctionDec 15, 2021Incorrect, 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: 370 MG/DL AND 141 MG/DL. ON (B)(6) 2021, THE PATIENT PERFORMED A SECOND COMPARISON WITH THE SAME TEST STRIPS WITHIN 15 MINUTES AND RECEIVED THE FOLLOWING RESULTS: 230 MG/DL AND 99 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13013761 ↗
• MalfunctionMay 4, 2021Incorrect, 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: 184 MG/DL, 514 MG/DL, AND 380 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11768969 ↗
• MalfunctionFeb 26, 2021Incorrect, 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: 200 MG/DL AND 95 MG/DL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11388560 ↗
• MalfunctionJan 25, 2021Incorrect, 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: 79 MG/DL AND 208 MG/DL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11226823 ↗
• MalfunctionJun 18, 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: 319 MG/DL,169 MG/DL AND 148 MG/DL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10168591 ↗
• MalfunctionJun 10, 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: 542 MG/DL AND 224 MG/DL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10140261 ↗
• MalfunctionApr 16, 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: 154 MG/DL AND 64 MG/DL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9968338 ↗
• MalfunctionDec 16, 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: 46 MG/DL ON AVIVA METER AND 107 MG/DL ON GUIDE METER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9472947 ↗
• MalfunctionNov 20, 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: 197 MG/DL, 108 MG/DL, 155 MG/DL AND 83 MG/DL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9347506 ↗
• MalfunctionSep 27, 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: 368 MG/DL, 210 MG/DL, AND 158 MG/DL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9127905 ↗