ACCU-CHEK SMART VIEW 06337546001Recalls & reported problems
Roche Diagnostics Operations, Inc. · ACCU-CHEK SMART VIEW 100CT STRIP 24/CS · Class 2
All models of ACCU-CHEK SMART VIEW (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Roche ACCU-CHEK Smart View test strip is used to check blood sugar at home. The 51 reports mostly describe strips giving readings that don't match, often far apart from another meter tested at the same time, and most people noticed no symptoms; a few reports mention hypoglycemia and sweating. There are no deaths and no injuries. One recall, started in March 2021 and still open, covers strips exposed to cold during shipping delays, which may cause inaccurate results.
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
- 51
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00365702493100), received between Sep 5, 2019 and Nov 28, 2022 — classified as 51 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (51 reports).
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Mar 16, 2021Class IIOpen, Classified
Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Z-1942-2021 · Root cause: Environmental control · Recall details · FDA record ↗
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings51
Patient problems
- No Consequences Or Impact To Patient29
- No Clinical Signs, Symptoms or Conditions15
- No Known Impact Or Consequence To Patient4
- Hypoglycemia3
- Sweating1
Recent adverse event reports
The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 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: 120 MG/DL WITH ACCU-CHEK NANO SYSTEM AND 240 MG/DL WITH ACCU-CHEK GUIDE SYSTEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15870738 ↗MalfunctionNov 15, 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: 285 MG/DL (SYSTEM 1) AND 144 MG/DL (SYSTEM 2).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15797486 ↗MalfunctionJul 14, 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: 400 MG/DL AND 150 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15013498 ↗MalfunctionMay 31, 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: 354MG/DL, 260 MG/DL AND 170 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14546958 ↗MalfunctionApr 20, 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: 230 MG/DL AND 72 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14164568 ↗MalfunctionMar 31, 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: 136 MG/DL AND 65 MG/DL. THE PATIENT EXPERIENCED HYPOGLYCEMIA AND WAS ABLE TO SELF-TREAT.
Patient problems: Hypoglycemia
MAUDE report 13965180 ↗MalfunctionNov 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: A RESULT OF EITHER 278 MG/DL OR 300 MG/DL AND A RESULT IN THE 120'S MG/DL. THE PATIENT COULD NOT RECALL THE EXACT VALUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12753970 ↗MalfunctionSep 3, 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: 206 MG/DL, 226 MG/DL, 140 MG/DL (SYSTEM 1) AND 118 MG/DL (SYSTEM 2). READINGS WERE OBTAINED WITH THE SAME VIAL OF TEST STRIPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12422722 ↗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: 379 MG/DL, 123 MG/DL AND 145 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12037193 ↗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: 306 MG/DL, 407 MG/DL, AND 164 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11949553 ↗MalfunctionJun 1, 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: 70 MG/DL (AVIVA) AND 117 MG/DL (NANO).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11915008 ↗MalfunctionMay 18, 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: 130 MG/DL AND APPROXIMATELY 200 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11841270 ↗MalfunctionMay 13, 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: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11821207 ↗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: 301 MG/DL, 157 MG/DL, 105 MG/DL, 137 MG/DL AND 80 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11770778 ↗MalfunctionApr 8, 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: 400 MG/DL, 90 MG/DL, AND 130 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11634360 ↗MalfunctionApr 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: 22 MG/DL AND 122 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11627910 ↗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: 172 MG/DL, 182 MG/DL AND 90 MG/DL USING THE NANO METER. THE PATIENT FELT LIKE HAVING LOW BLOOD SUGARS AND WAS ABLE TO SELF-TREAT BY TAKING FAST ACTING GLUCOSE SUPPLEMENT.
Patient problems: Hypoglycemia
MAUDE report 11387971 ↗MalfunctionFeb 9, 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: 130 MG/DL AND 293 MG/DL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11301181 ↗MalfunctionDec 22, 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: 119 MG/DL AND 55 MG/DL.
Patient problems: Hypoglycemia; Sweating
MAUDE report 11055017 ↗MalfunctionDec 12, 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: 253 MG/DL AND 99 MG/DL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10995159 ↗MalfunctionDec 8, 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: 267 MG/DL AND 130 MG/DL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10969447 ↗MalfunctionDec 7, 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: 201 MG/DL, 113 MG/DL, 90 MG/DL, AND 89 MG/DL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10961537 ↗MalfunctionNov 17, 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: 61 MG/DL, 122 MG/DL AND 130 MG/DL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10852108 ↗MalfunctionNov 12, 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: 396 MG/DL (SYSTEM 1) AND 141 MG/DL (SYSTEM 2).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10829683 ↗MalfunctionOct 27, 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: 76 MG/DL (SYSTEM 1) AND 173 MG/DL (SYSTEM 2).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10742579 ↗
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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 · each recall links to the FDA recall notice
- 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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