ACCU-CHEK AVIVA PLUSRecalls & reported problems across all models
Roche Diagnostics Operations, Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,167
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls
- 0
We found 5 models of ACCU-CHEK AVIVA PLUS by Roche Diagnostics Operations, Inc. in the FDA's device registry (GUDID). Together they are named in 1,167 adverse event reports in the FDA's MAUDE database, received between Sep 5, 2019 and Jan 20, 2026 — classified as 24 injuries, 1,143 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1,108 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported ACCU-CHEK AVIVA PLUS problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1,108
- Imprecise or Erratic Results26
- High Test Results18
- Adverse Event Without Identified Device or Use Problem3
- Low Test Results3
- High Readings2
- Low Readings2
- Device Displays Incorrect Message1
Patient problems
- No Consequences Or Impact To Patient516
- No Clinical Signs, Symptoms or Conditions381
- No Known Impact Or Consequence To Patient174
- Hypoglycemia62
- Hyperglycemia17
- Shaking/Tremors9
- Dizziness4
- Loss of consciousness3
ACCU-CHEK AVIVA PLUS models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ACCU-CHEK AVIVA PLUS 06908268001Glucose Dehydrogenase, Glucose472 reports
- ACCU-CHEK AVIVA PLUS 06908349001Glucose Dehydrogenase, Glucose337 reports
- ACCU-CHEK AVIVA PLUS 06908217001Glucose Dehydrogenase, Glucose335 reports
- ACCU-CHEK AVIVA PLUS 06908373001Glucose Dehydrogenase, Glucose20 reports
- ACCU-CHEK AVIVA PLUS 06908152001Glucose Dehydrogenase, Glucose3 reports
Recent ACCU-CHEK AVIVA PLUS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJan 20, 2026Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 200 MG/DL, 120 MG/DL, 60 MG/DL AND 90 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24117522 ↗MalfunctionJan 6, 2026Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: (B)(6)-2026 7:30 AM, 431 MG/DL. (B)(6)-2026, 7:33 AM, 176 MG/DL. (B)(6)-2026, 7:36 AM, 87 MG/DL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23975030 ↗MalfunctionAug 29, 2025High Test Results; High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 219 MG/DL AT 10:10 AM (AVIVA). 90 MG/DL AT 10:10 AM (PROFESSIONAL METER).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22924145 ↗MalfunctionAug 27, 2025Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 70 MG/DL AND 176 MG/DL. THE PATIENT EXPERIENCED HYPOGLYCEMIA SYMPTOMS OF FEELING PALE AS IF SHE WAS GOING TO FAINT. THE PATIENT SELF-TREATED WITH JUICE AND CRACKERS.
Patient problems: Hypoglycemia
MAUDE report 22903400 ↗InjuryJul 31, 2025High Test Results; High Test Results
IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVEL WAS OVER 200 MG/DL ON (B)(6) /2025 AT 8:30 P.M. THE PATIENT ADMINISTERED 1 UNIT OF HUMALOG INSULIN BASE ON THE BLOOD GLUCOSE RESULT. AROUND AN HOUR LATER, AT 9:30 P.M., A NEW READING SHOWED HER BLOOD GLUCOSE HAD RISEN TO 250 MG/DL. BELIEVING THE FIRST DOSE WAS INEFFECTIVE, SHE DELIVERED AN ADDITIONAL 0.5 UNITS OF HUMALOG INSULIN. AROUND 10:30 P.M., SHE AWOKE TO A BLOOD GLUCOSE READING OF 30 MG/DL. SHE WAS UNABLE TO SELF-TREAT AND CALLED HER SISTER FOR HELP. THE PATIENT REPORTED A PANIC ATTACK AND DIFFICULTY BREATHING BEFORE LOSING CONSCIOUSNESS FOR AN ESTIMATED 3 TO 5 MINUTES. THE PATIENT'S SISTER PROVIDED TREATMENT WITH TWO TO THREE GRAPES AT AROUND 10:30 P.M. OR 11:00 P.M. AN ATTEMPT WAS MADE TO CALL THE PARAMEDICS, BUT THE PHONE WAS NOT WORKING. THE PATIENT WAS NOT TAKEN TO A MEDICAL FACILITY.
Patient problems: Loss of consciousness
MAUDE report 22677580 ↗MalfunctionJul 23, 2025High Test Results; High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 414 MG/DL AND 179 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22575172 ↗MalfunctionJul 22, 2025Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 400 MG/DL, 500 MG/DL, 59 MG/DL AND 189 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22563737 ↗MalfunctionJun 18, 2025Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 70 MG/DL AND 276 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22283259 ↗MalfunctionJun 16, 2025Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 260 MG/DL, 200 MG/DL AND 91 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22211405 ↗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 ↗MalfunctionMay 23, 2025Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 112 MG/DL AND 235 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22078920 ↗MalfunctionMay 19, 2025Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 64 MG/DL, 280 MG/DL AND 364 MG/DL.
Patient problems: Numbness
MAUDE report 22044402 ↗MalfunctionMay 13, 2025Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 254 MG/DL AND "LO" MG/DL (= LESS THAN 20 MG/DL).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22009258 ↗MalfunctionMay 6, 2025Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 300 MG/DL AND 40 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21970817 ↗MalfunctionApr 25, 2025Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 218 MG/DL, 146 MG/DL AND 109 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21907597 ↗
Other Roche Diagnostics Operations, Inc. products
All Roche Diagnostics Operations, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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