ACCU-CHEK SMART VIEW 06337538001Recalls & reported problems
Roche Diagnostics Operations, Inc. · ACCU-CHEK SMART VIEW 50CT STRIP 36/CS · Class 2
All models of ACCU-CHEK SMART VIEW (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Roche ACCU-CHEK Smart View test strip is used to check blood sugar at home. Most of the 37 reports describe strips giving readings that were wrong or inconsistent, such as results jumping from very high to very low within minutes, and one vial whose printed expiration date did not match the lot's real expiration date. One report involved an injury, and there were 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
- 37
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00365702492103), received between Sep 23, 2019 and Oct 27, 2025 — classified as 1 injury, 36 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (34 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 Readings34
- Imprecise or Erratic Results1
- Labelling, Instructions for Use or Training Problem1
- Low Test Results1
Patient problems
- No Consequences Or Impact To Patient16
- No Clinical Signs, Symptoms or Conditions15
- No Known Impact Or Consequence To Patient3
- Hypoglycemia2
- Hyperglycemia1
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 27, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem
IT WAS REPORTED THAT THE EXPIRATION DATE LABELED ON THE TEST STRIP VIAL WAS 25-AUG-2031. THE ACTUAL EXPIRATION DATE IS 31-AUG-2025 FOR LOT NUMBER 671232.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23390134 ↗MalfunctionJun 9, 2025Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 320 MG/DL, 220 MG/DL, AND 90 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22168115 ↗InjuryAug 22, 2024Low Test Results; Low Test Results
THE MOTHER REPORTED THAT THE BLOOD GLUCOSE DEVICE GAVE A LOWER THAN EXPECTED READING DURING A HYPERGLYCEMIC EVENT. THE USER RECEIVED A BLOOD GLUCOSE RESULT OF 117 MG/DL A LITTLE BEFORE 12:00PM ON HIS ACCU-CHEK NANO SYSTEM. THE USER STATED THAT HE DID NOT HAVE AN APPETITE AND WAS NOT FEELING GOOD AT THIS TIME. AT APPROXIMATELY 12:35PM THE USER'S PARENT'S NOTICED THAT THE CUSTOMER DID NOT "LOOK GOOD AROUND THE EYES" AND THEY TRANSPORTED THE CUSTOMER TO THE HOSPITAL AT AROUND 1:00PM. UPON ARRIVAL AT THE HOSPITAL THE USER RECEIVED A BLOOD GLUCOSE RESULT OVER 1000 MG/DL. THE HOSPITAL TREATED THE CUSTOMER WITH INSULIN AND OTHER FLUIDS VIA IV. THE CUSTOMER WAS ALSO GIVEN ANTIBIOTICS AS HE HAD DEVELOPED THRUSH DURING HIS HOSPITALIZATION. THE CUSTOMER WAS HOSPITALIZED FOR ONE WEEK.
Patient problems: Hyperglycemia
MAUDE report 20039358 ↗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: 233 MG/DL AND 93 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19665766 ↗MalfunctionMay 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: 43MG/DL AND 163 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19277882 ↗MalfunctionMay 8, 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: 510 MG/DL, 355 MG/DL, 205 MG/DL, 206 MG/DL, 202 MG/DL AND 242 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19267616 ↗MalfunctionSep 19, 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, 143 MG/DL AND 101 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17778155 ↗MalfunctionJun 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: 176 MG/DL, 409 MG/DL AND 251 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17222976 ↗MalfunctionJun 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: 412 MG/DL AND 187 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17170337 ↗MalfunctionDec 21, 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: 240 MG/DL (SYSTEM 1) AND 118 MG/DL (SYSTEM 2).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16022038 ↗MalfunctionApr 11, 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: 114 MG/DL, 105 MG/DL, 111 MG/DL, 195 MG/DL AND 125 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14074742 ↗MalfunctionJan 13, 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 259 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13248459 ↗MalfunctionDec 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: 114 MG/DL (SYSTEM 1) AND 240 MG/DL "SOMETHING" (SYSTEM 2).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13099531 ↗MalfunctionSep 14, 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: 207 MG/DL AND 57 MGD/L.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12466417 ↗MalfunctionAug 2, 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: AT 2:24 P.M. 123 MG/DL (SYSTEM 1), AT 2:27 P.M. 292 MG/DL (SYSTEM 1) , AT 2:28 P.M. 224 MG/DL (SYSTEM 1), AT 2:31 P.M. 131 MG/DL (SYSTEM 1), AT 2:33 P.M. 144 MG/DL (SYSTEM 1), AT 2:43 P.M. 221 MG/DL (SYSTEM 1), AT 2:47 P.M. 137 MG/DL (SYSTEM 1), AT 2:33 P.M. 144 MG/DL (SYSTEM 2), AT 2:40 P.M. 130 MG/DL (SYSTEM 2), AT 2:43 P.M. 221 MG/DL (SYSTEM 2), AND AT 2:45 P.M. 101 MG/DL (SYSTEM 2).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12263306 ↗MalfunctionJun 15, 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: 109 MG/DL WITH THE ACCU-CHEK AVIVA METER AND 263 MG/DL WITH THE ACCU-CHEK NANO METER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11997305 ↗MalfunctionMar 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: 92 MG/DL AND 205 MG/DL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11391960 ↗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: 127 MG/DL (SYSTEM 1) AND 57 MG/DL (SYSTEM 2). THE PATIENT EXPERIENCED HYPOGLYCEMIA SYMPTOMS OF DIZZINESS.
Patient problems: Hypoglycemia
MAUDE report 11301284 ↗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: 127 MG/DL (SYSTEM 1) AND 57 MG/DL (SYSTEM 2). THE PATIENT EXPERIENCED HYPOGLYCEMIA SYMPTOMS OF DIZZINESS.
Patient problems: Hypoglycemia
MAUDE report 11301266 ↗MalfunctionDec 15, 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: 407 MG/DL AND 179 MG/DL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11015090 ↗MalfunctionDec 14, 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: 246 MG/DL AND 113 MG/DL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11003830 ↗MalfunctionNov 10, 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: 350 MG/DL AND 153 MG/DL. THE CALLER REPORTED THAT THE RESULTS WERE OBTAINED USING THE SAME VIAL OF TEST STRIPS, BUT COULD NOT PROVIDE WHICH LOT (478936 OR 478652) WAS IN USE AT THE TIME OF THE READINGS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10816830 ↗MalfunctionSep 24, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 2 MINUTES: 218 MG/DL (LOT 478936) AND 94 MG/DL (LOT 478881) WITH THE SAME ACCU-CHEK NANO METER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10581932 ↗MalfunctionAug 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: 404 MG/DL, 154 MG/DL AND 199 MG/DL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10459473 ↗MalfunctionJul 24, 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: 78 MG/DL, 230 MG/DL AND 456 MG/DL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10319632 ↗
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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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