ACCU-CHEK SMART VIEWRecalls & reported problems across all models
Roche Diagnostics Operations, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one ACCU-CHEK SMART VIEW model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 88
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 2 models of ACCU-CHEK SMART VIEW by Roche Diagnostics Operations, Inc. in the FDA's device registry (GUDID). Together they are named in 88 adverse event reports in the FDA's MAUDE database, received between Sep 5, 2019 and Oct 27, 2025 — classified as 1 injury, 87 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (85 reports).
1 FDA recall record name at least one of these models by its device 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. 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
ACCU-CHEK SMART VIEW recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Mar 16, 2021Open, 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 ACCU-CHEK SMART VIEW problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings85
- Imprecise or Erratic Results1
- Labelling, Instructions for Use or Training Problem1
- Low Test Results1
Patient problems
- No Consequences Or Impact To Patient45
- No Clinical Signs, Symptoms or Conditions30
- No Known Impact Or Consequence To Patient7
- Hypoglycemia5
- Hyperglycemia1
- Sweating1
ACCU-CHEK SMART VIEW models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ACCU-CHEK SMART VIEW 06337546001Glucose Dehydrogenase, Glucose1 recall51 reports
- ACCU-CHEK SMART VIEW 06337538001Glucose Dehydrogenase, Glucose37 reports
Recent ACCU-CHEK SMART VIEW adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗
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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