ACCU-CHEK AVIVA PLUS 06908268001Recalls & reported problems
Roche Diagnostics Operations, Inc. · ACCU-CHEK AVIVA PLUS 100CT STRP BRK 24/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 test strip is used with a meter to check blood glucose. Most of its 472 reports describe inaccurate or erratic readings, including results that came out too high or too low, and a few mention low or high blood sugar symptoms. The reports include 8 injuries and no deaths, and reports in the last 12 months fell to 2 from 18 before. 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
- 472
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 472 adverse event reports that list this exact device (DI 00365702408104), received between Sep 5, 2019 and Jan 20, 2026 — classified as 8 injuries, 464 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (440 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 Readings440
- Imprecise or Erratic Results14
- High Test Results10
- Low Test Results3
- High Readings2
- Adverse Event Without Identified Device or Use Problem1
- Inadequate User Interface1
- Labelling, Instructions for Use or Training Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions216
- No Consequences Or Impact To Patient168
- No Known Impact Or Consequence To Patient50
- Hypoglycemia21
- Hyperglycemia8
- Shaking/Tremors4
- Loss of consciousness2
- Convulsion/Seizure1
Recent adverse event reports
The 25 most recent of 472 reports, 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 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 ↗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 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 ↗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 ↗MalfunctionApr 17, 2025Low Test Results; Low Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 532 MG/DL (USER'S METER), 469 MG/DL (USER'S METER) AND 113 MG/DL (DIFFERENT ROCHE METER).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21854105 ↗MalfunctionMar 25, 2025High Test Results; High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 367 MG/DL AND 143 MG/DL.
Patient problems: Hyperglycemia
MAUDE report 21685384 ↗MalfunctionMar 11, 2025Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 108 MG/DL AND 48 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21573769 ↗MalfunctionFeb 19, 2025High Test Results; High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 346 MG/DL AND 147 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21408830 ↗MalfunctionFeb 3, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem
IT WAS ALLEGED BY THE PATIENT THAT THE EXPIRATION DATE PRINTED ON THE TEST STRIP VIAL WAS "2025 (B)(4)" WHICH IS INVALID. THE ACTUAL EXPIRATION DATE SHOULD BE LABELED AS (2024 (B)(4)) ON THE TEST STRIP VIAL FOR LOT NUMBER (690378). THE TEST STRIPS ARE EXPIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21292014 ↗MalfunctionJan 31, 2025Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 388 MG/DL, 156 MG/DL, 80 MG/DL, AND 52 MG/DL. THE PATIENT EXPERIENCED SYMPTOMS OF TINGLING ON THE BACK OF HER NECK AND LIGHTHEADEDNESS AT THE TIME OF THE 52 MG/DL RESULT. THE PATIENT WAS CAPABLE OF SELF-TREATING HER HYPOGLYCEMIA BY OBTAINING AND CONSUMING YOGURT AND SALTINE CRACKERS WITHOUT ASSISTANCE. THE PATIENT FELT BETTER 30 TO 40 MINUTES AFTER CONSUMING THE FOOD.
Patient problems: Hypoglycemia
MAUDE report 21285041 ↗MalfunctionJan 31, 2025High Test Results; High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 482 MG/DL, 177 MG/DL, AND 261 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21284964 ↗MalfunctionJan 6, 2025High Test Results; High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 148 MG/DL, 430 MG/DL, 148 MG/DL, HI (= HIGHER THAN THE MEASUREMENT RANGE OF THE METER) AND 148 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21078709 ↗MalfunctionNov 28, 2024Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 88 MG/DL AT 5:47AM, 172 MG/DL AT 5:51AM, 129 MG/DL AT 5:51AM, 108 MG/DL AT 5:51AM, 162 MG/DL AT 5:52AM AND 126 MG/DL AT 5:52AM.
Patient problems: Shaking/Tremors
MAUDE report 20804837 ↗MalfunctionOct 31, 2024High Test Results; High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: "HI" MG/DL (GREATER THAN 600 MG/DL) AND 222 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20580313 ↗MalfunctionOct 11, 2024Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 55 MG/DL, 82 MG/DL, 52 MG/DL, AND 49 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20433435 ↗MalfunctionOct 7, 2024Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 55 MG/DL AND 226 MG/DL. THE CUSTOMER HAD LOW BLOOD SUGAR SYMPTOMS OF SWEATING. SHE SELF-TREATED BY EATING CRACKERS WITH PEANUT BUTTER AND FELT BETTER.
Patient problems: Diaphoresis
MAUDE report 20391330 ↗MalfunctionAug 28, 2024High Test Results; High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 333 MG/DL (AVIVA SYSTEM) AND 165 MG/DL (GUIDE SYSTEM).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20088075 ↗MalfunctionJul 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: ON (B)(6) 2024 252 MG/DL AND 123 MG/DL AND ON (B)(6) 2024 217 MG/DL AND BETWEEN 115-125 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19706677 ↗
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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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