ACCU-CHEK AVIVA PLUS 06908217001Recalls & reported problems
Roche Diagnostics Operations, Inc. · ACCU-CHEK AVIVA PLUS 50CT STRIP BRK 36/C · Class 2
All models of ACCU-CHEK AVIVA PLUS (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Roche Accu-Chek Aviva Plus blood glucose test strip is used to measure blood sugar. Its 335 reports mostly describe glucose readings that are wrong or inconsistent, with some patients getting very different results in quick succession. The reports mention 11 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 335
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 335 adverse event reports that list this exact device (DI 00365702407107), received between Sep 5, 2019 and Jul 23, 2025 — classified as 11 injuries, 324 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (317 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
- Incorrect, Inadequate or Imprecise Result or Readings317
- Imprecise or Erratic Results11
- High Test Results3
- Adverse Event Without Identified Device or Use Problem2
- Low Readings2
Patient problems
- No Consequences Or Impact To Patient130
- No Clinical Signs, Symptoms or Conditions125
- No Known Impact Or Consequence To Patient45
- Hypoglycemia23
- Hyperglycemia6
- Shaking/Tremors4
- Coma2
- Dizziness2
Recent adverse event reports
The 25 most recent of 335 reports, in the reporter's own words as published by the FDA.
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 ↗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 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 ↗MalfunctionMar 27, 2025Imprecise or Erratic Results; Imprecise or Erratic Results
ON (B)(6) 2025 THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 454 MG/DL, 121 MG/DL, AND 82 MG/DL. ON (B)(6) 2025, THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 450 MG/DL, 120 MG/DL, AND 80 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21710161 ↗MalfunctionMar 18, 2025Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 70'S (MG/DL) AND 180'S (MG/DL).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21635568 ↗MalfunctionFeb 25, 2025High Test Results; High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 311 MG/DL (SYSTEM 1) AND 153 MG/DL (SYSTEM 2).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21460343 ↗MalfunctionFeb 11, 2025Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 243 MG/DL AND A RESULT IN THE 100 MG/DL RANGE. AT ANOTHER TIME, THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 256 MG/DL AND A RESULT IN THE 100 MG/DL RANGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21356333 ↗MalfunctionJan 15, 2025High Test Results; High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 328 MG/DL AND 160 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21158416 ↗MalfunctionNov 27, 2024Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 322 MG/DL, 158 MG/DL, 137 MG/DL, 83 MG/DL, AND 126 MG/DL. THE CUSTOMER WAS FEELING LOW BLOOD SUGAR SYMPTOMS AND WAS ABLE TO SELF-TREAT.
Patient problems: Shaking/Tremors
MAUDE report 20797207 ↗MalfunctionOct 15, 2024Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 120 MG/DL AND 60 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20448959 ↗MalfunctionSep 16, 2024Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 91 MG/DL, 180 MG/DL AND 93 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20226514 ↗MalfunctionSep 16, 2024Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 162 MG/DL AND 86 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20226473 ↗MalfunctionAug 28, 2024Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 455 MG/DL AND 149 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20084199 ↗MalfunctionJul 23, 2024Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING SETS OF RESULTS WITHIN 15 MINUTES: SYSTEM 1: AT 9:58AM A READING OF 357 MG/DL. AT 9:59AM A READING OF 226 MG/DL. AT 10:02AM A READING OF 135 MG/DL. AT 10:34AM A READING OF 354 MG/DL. AT 10:35AM A READING OF 203 MG/DL. AT 10:36 AM A READING OF 164 MG/DL. SYSTEM 2: AT 10:50AM A READING OF 355 MG/DL. AT 10:59AM A READING OF 202 MG/DL. AT 11:00AM A READING OF 117 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19812002 ↗MalfunctionJul 3, 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: 688 MG/DL AND 180 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19665550 ↗MalfunctionApr 15, 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: 114 MG/DL AND 305 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19112262 ↗MalfunctionApr 15, 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: 123 MG/DL AND 262 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19110925 ↗MalfunctionMar 18, 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: 230 MG/DL AND 115 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18927026 ↗MalfunctionMar 13, 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: 33 MG/DL (SYSTEM 1) AND 98 MG/DL (SYSTEM 2).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18893757 ↗MalfunctionMar 13, 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: 33 MG/DL (SYSTEM 1) AND 98 MG/DL (SYSTEM 2).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18893749 ↗MalfunctionFeb 19, 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: 331 MG/DL, 83 MG/DL, AND 321 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18730607 ↗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: 97 MG/DL AND 402 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18377709 ↗MalfunctionNov 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: 230 MG/DL, 98 MG/DL, AND 98 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18237569 ↗MalfunctionNov 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: 40 MG/DL (SYSTEM 1) AND 300 MG/DL (SYSTEM 2).
Patient problems: Hypoglycemia; Shaking/Tremors
MAUDE report 18237046 ↗MalfunctionNov 29, 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: 70 MG/DL (PATIENT´S METER) AND 21 MG/DL (PROFESSIONAL´S METER).
Patient problems: Hypoglycemia
MAUDE report 18232755 ↗
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- FreeStyle Lite 70805Abbott Diabetes Care Inc · Glucose dehydrogenase, glucose2,366 reports
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- FreeStyle Freedom Lite 70914Abbott Diabetes Care Inc · Glucose dehydrogenase, glucose760 reports
- Accu-Chek Guide 08256292001Roche Diagnostics Operations, Inc. · Glucose Dehydrogenase, Glucose476 reports
- ACCU-CHEK AVIVA PLUS 06908268001Roche Diagnostics Operations, Inc. · Glucose Dehydrogenase, Glucose472 reports
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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