ACCU-CHEK AVIVA PLUS 06908349001Recalls & reported problems

Summary

The FDA's MAUDE database contains 337 adverse event reports that list this exact device (DI 00365702438101), received between Sep 6, 2019 and Feb 7, 2025 — classified as 5 injuries, 332 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (330 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 25 most recent of 337 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2025High Test Results; High Test Results

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 480 MG/DL AND 110 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21330992 ↗
• MalfunctionMay 21, 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: 487 MG/DL AND 50 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19363009 ↗
• MalfunctionNov 16, 2023Expiration Date Error; Expiration Date Error

  THE CALLER REPORTED THAT THE TEST STRIPS LISTED AN EXPIRATION DATE OF 9/30/2024 ON THE VIAL. THE ALLEGED LABELING IS INCORRECT. THE EXPIRATION DATE OF STRIP LOT.498722 IS 09/30/2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18148606 ↗
• MalfunctionMay 22, 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: 477 MG/DL, 205 MG/DL, AND 266 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16972968 ↗
• MalfunctionFeb 6, 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: 479 MG/DL AND 210 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16305580 ↗
• MalfunctionJan 23, 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: 155 MG/DL AND 410 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16224516 ↗
• MalfunctionOct 5, 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: 235 MG/DL (AVIVA) AND 99 MG/DL (HOSPITAL METER).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15544921 ↗
• MalfunctionOct 4, 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: 261 MG/DL AND 127 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15536265 ↗
• MalfunctionJun 1, 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: 384 MG/DL AND 160 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14567669 ↗
• MalfunctionMay 6, 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: 486 MG/DL, 324 MG/DL, AND 195 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14308221 ↗
• MalfunctionApr 28, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CALLER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON AN AVIVA METER, COMPARED TO A PROFESSIONAL METER, WITHIN 15 MINUTES: 182 MG/DL (AVIVA) AND 89 MG/DL (DOCTOR'S METER). THE TEST STRIPS ARE CURRENTLY EXPIRED, HOWEVER THE CUSTOMER REPORTED THAT THE TEST STRIPS WERE NOT EXPIRED AT THE TIME OF THE COMPARISON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14241115 ↗
• MalfunctionFeb 17, 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: HI MG/DL (WHICH ON THE SYSTEM INDICATES A RESULT IN EXCESS OF 600 MG/DL) AND 148 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13547600 ↗
• MalfunctionOct 12, 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: 211 MG/DL AND 84 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12616624 ↗
• MalfunctionSep 28, 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: 44 MG/DL, 200 MG/DL, AND 212 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12540853 ↗
• MalfunctionSep 24, 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: A RESULT IN THE 300'S MG/DL AND A RESULT OF EITHER 75 MG/DL OR 80 MG/DL. THE CUSTOMER COULD NOT RECALL THE EXACT VALUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12526119 ↗
• MalfunctionJun 29, 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: 264 MG/DL, 271 MG/DL, LO MG/DL, 287 MG/DL AND 80 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12085573 ↗
• MalfunctionJun 29, 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: 264 MG/DL, 271 MG/DL, LO MG/DL, 287 MG/DL AND 80 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12085529 ↗
• MalfunctionJun 28, 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: 257 MG/DL AND 281 MG/DL (SYSTEM 1) AND 115 MG/DL AND 131 MG/DL (SYSTEM 2).

  Patient problems: Hypoglycemia; Shaking/Tremors

  MAUDE report 12076007 ↗
• MalfunctionJun 21, 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: 356 MG/DL, 157 MG/DL AND 160 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12036389 ↗
• InjuryJun 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT RECEIVED A HIGH BLOOD GLUCOSE RESULT OF 200 MG/DL WHILE EXPERIENCING AN EPISODE OF HYPOGLYCEMIA. AROUND 4-5PM, THE PATIENT'S SYMPTOMS OF LOW BLOOD SUGAR WERE IMPAIRED SPEECH, NO CONTROL OVER HIS BODY MOVEMENTS, AND HE WAS INCOHERENT. THE PATIENT DID NOT TREAT DURING THIS TIME. BETWEEN 6-7PM, THE CUSTOMER BEGAN TO HAVE A SEIZURE. DUE TO THE IMPACT OF THE SEIZURE, THE CUSTOMER WAS NOT CAPABLE OF PERFORMING A BLOOD TEST ON HIS OWN. THEREFORE, HIS SON PERFORMED A BLOOD TEST FOR HIM AND RECEIVED A RESULT OF 200 MG/DL. THE CUSTOMER'S SON CALLED THE EMTS AROUND 7PM. WHEN THE EMTS ARRIVED THEY PERFORMED A BLOOD TEST ON THEIR METER AND RESULT WAS 50 MG/DL. BASED ON THE RESULT, THE PATIENT WAS TREATED WITH A GEL SUBSTANCE AND WAS TRANSPORTED TO THE MEDICAL CENTER FOR ADDITIONAL TREATMENT. THEY ARRIVED AT 9:59PM TO THE MEDICAL CENTER, WHERE THE PATIENT RECEIVED AN IV, BUT HE DOES NOT KNOW WHAT MEDICATION HE RECEIVED. THE CUSTOMER WAS NOT ADMITTED INTO THE MEDICAL CENTER, BUT WAS KEPT FOR SEVERAL HOURS FOR OBSERVATION. THE CUSTOMER WAS DISCHARGED ABOUT 2:45AM WITH A STEADY BLOOD GLUCOSE LEVEL AND ARRIVED BACK HOME ABOUT 3:00AM ON (B)(6) 2021. THE PATIENT WAS USING E

  Patient problems: Hypoglycemia

  MAUDE report 12035687 ↗
• MalfunctionJun 7, 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: 179 MG/DL, 193 MG/DL, 299 MG/DL, AND 76 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11948063 ↗
• MalfunctionMay 27, 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: 497 MG/DL AND 194 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11895239 ↗
• MalfunctionMay 20, 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: 316 MG/DL (SYSTEM 1) AND 142 MG/DL (SYSTEM 2).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11857037 ↗
• MalfunctionMay 10, 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: 243 M/GDL (AVIVA) AND 126 MG/DL (GUIDE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11797836 ↗
• MalfunctionMay 7, 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 USING TWO BLOOD GLUCOSE MONITORS: 578 MG/DL AND A RESULT IN THE 140'S (MG/DL) WITH THE GUIDE METER (SYSTEM 1) AND 137 MG/DL WITH THE AVIVA METER (SYSTEM 2).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11792458 ↗