Accu-Chek Guide 08256292001Recalls & reported problems
Roche Diagnostics Operations, Inc. · Accu-Chek Guide 50ct HN 36/cs · Class 2
All models of ACCU-CHEK GUIDE (14)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Accu-Chek Guide blood glucose test system is used to check blood sugar at home. Its 476 adverse event reports mostly describe readings that were incorrect, erratic, or much higher or lower than repeat tests taken minutes apart. There are no deaths and 10 injuries. Reports fell from 56 in the prior 12 months to 15 in the last 12. 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
- 476
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 476 adverse event reports that list this exact device (DI 00365702719101), received between Mar 31, 2020 and Sep 28, 2026 — classified as 10 injuries, 466 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (372 reports).
2 other recalls cover devices cleared under the same FDA submission (K160944); they may or may not involve this specific model.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings372
- Imprecise or Erratic Results55
- High Test Results41
- Low Test Results2
- Adverse Event Without Identified Device or Use Problem1
- Device Markings/Labelling Problem1
- Display Difficult to Read1
- High Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions364
- No Consequences Or Impact To Patient55
- Hypoglycemia31
- Hyperglycemia12
- Blurred Vision5
- Dizziness5
- Fatigue5
- Shaking/Tremors5
Recent adverse event reports
The 25 most recent of 476 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026High Test Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917613 ↗MalfunctionSep 25, 2026High Test Results
It was reported the patient received the following results within 15 minutes: 479 mg/dL and 126 mg/dL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897028 ↗MalfunctionMar 19, 2026High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 84 MG/DL (SYSTEM 1) AND 163 MG/DL (SYSTEM 2). THE BLOOD GLUCOSE RESULTS WERE OBTAINED USING THE SAME VIAL OF TEST STRIPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24641174 ↗MalfunctionFeb 24, 2026Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 300 MG/DL, 215 MG/DL, 439 MG/DL AND 209 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24427540 ↗MalfunctionFeb 12, 2026Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 354 MG/DL AND 119 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24321778 ↗MalfunctionFeb 9, 2026High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 601 MG/DL AND 201 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24291919 ↗MalfunctionJan 30, 2026Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: HI MG/DL AT 9:11AM (WHICH ON THE SYSTEM INDICATES A RESULT IN EXCESS OF 600 MG/DL) 258 MG/DL AT 9:12AM, 222 MG/DL AT 9:13AM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24219426 ↗MalfunctionJan 29, 2026High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 550 MG/DL AND 150 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24209016 ↗MalfunctionJan 20, 2026High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 320 MG/DL (USER'S METER) AND 109 MG/DL (PROFESSIONAL'S METER).
Patient problems: Hypoglycemia
MAUDE report 24113811 ↗MalfunctionDec 9, 2025Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 400'S MG/DL AND 90'S MG/DL. AND THEN ON A SEPARATE DAY THE USER TESTED AGAIN AND RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 300'S MG/DL AND 90'S MG/DL. THE USER COULD NOT RECALL THE EXACT VALUES FOR EACH SET OF COMPARISONS. THE USER STATED THAT THE READINGS WERE OBTAINED USING THE SAME VIAL OF STRIPS, LOT. 102981, AND THAT THE TEST STRIPS WERE NOT EXPIRED AT THE TIME OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23758316 ↗MalfunctionDec 1, 2025Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 524 MG/DL, 181 MG/DL AND 131 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23680063 ↗MalfunctionDec 1, 2025Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 493 MG/DL AND 199 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23679753 ↗MalfunctionNov 21, 2025High Test Results; High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 192 MG/DL AND 100 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23619292 ↗InjuryNov 11, 2025Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THAT THE PATIENT RECEIVED THE FOLLOWING RESULTS OVER A PERIOD OF SEVERAL HOURS DURING THE INCIDENT DAY: 104 MG/DL, 120 MG/DL, 89 MG/DL, 125 MG/DL AND 130 MG/DL. AT AN UNKNOWN TIME ON THAT DAY, THE PATIENT WAS NOT FEELING WELL, EXPERIENCED SYMPTOMS LIKE DIZZINESS, AND PASSED OUT. THE PATIENT´S WIFE AND DAUGHTER CALLED THE PARAMEDICS WHO GAVE THE PATIENT AN UNKNOWN AMOUNT OF INSULIN AS TREATMENT. THE PATIENT WAS STABILIZED AND NOT TAKEN TO THE HOSPITAL.
Patient problems: Dizziness; Loss of consciousness
MAUDE report 23520106 ↗MalfunctionNov 5, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem
THE USER REPORTED THE USE BY DATE LISTED ON THE TEST STRIP VIAL WAS 2026-05-20. THE CORRECT EXPIRATION DATE FOR LOT. 104526 IS 2025-05-20.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23477604 ↗MalfunctionOct 24, 2025Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 222 MG/DL @ 01:00PM ON (B)(6) 2025, 98 MG/DL @ 01:02PM ON (B)(6) 2025. 123 MG/DL @ 03:00PM ON (B)(6) 2025, 379 MG/DL @ 03:02PM ON (B)(6) 2025. 341 MG/DL @ 03:00PM ON (B)(6) 2025, 141 MG/DL @ 03:02PM ON (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23378415 ↗MalfunctionOct 16, 2025High Test Results; High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 237 MG/DL, 213 MG/DL AND 514 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23307689 ↗MalfunctionOct 15, 2025Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 200 MG/DL, 76 MG/DL AND 69 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23288467 ↗MalfunctionSep 15, 2025High Test Results; High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: ON (B)(6) 2025 A READING OF 800 MG/DL AT 6:30 AM. ON (B)(6) 2025 A READING OF 140 MG/DL AT 6:34 AM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23051650 ↗MalfunctionAug 25, 2025High Test Results; High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 534 MG/DL AND 123 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22882938 ↗MalfunctionAug 18, 2025High Test Results; High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 473 MG/DL AT 5:00 AM. 465 MG/DL AT 5:05 AM. 158 MG/DL AT 5:08 AM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22832187 ↗MalfunctionJul 24, 2025Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 107 MG/DL, 400 MG/DL, AND 300 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22585774 ↗MalfunctionJul 8, 2025Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: HI (= HIGHER THAN 600 MG/DL), 175 MG/DL AND 554 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22435322 ↗MalfunctionJul 3, 2025Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 29 MG/DL AT 5:00AM . 288 MG/DL AT 5:01AM . 131 MG/DL AT 5:02AM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22399297 ↗MalfunctionJun 23, 2025Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 362 MG/DL AND 167 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22307113 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K160944. One submission often covers many models, so check the product and lot details in each record.
- Z-2174-2024 · May 13, 2024 · Open, ClassifiedAccu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectivenes
- Z-0747-2020 · Sep 30, 2019 · TerminatedBlood Glucose Monitoring System, Model Number 07400870001 ACCU-CHEK GUIDE SAMPLE KIT MG/DL - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quant
Other Glucose Dehydrogenase, Glucose devices
- OneTouch Verio IQ 022-275LifeScan Europe GmbH · Glucose dehydrogenase, glucose6,035 reports
- OneTouch Verio 022-659LifeScan Europe GmbH · Glucose dehydrogenase, glucose4,219 reports
- TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE TEST STRIPS - 50 Test StripsTrividia Health, Inc. · Glucose Dehydrogenase, Glucose2 deaths2,548 reports
- FreeStyle Lite 70805Abbott Diabetes Care Inc · Glucose dehydrogenase, glucose2,366 reports
- FreeStyle Freedom Lite 70920Abbott Diabetes Care Inc · Glucose dehydrogenase, glucose1,037 reports
- FreeStyle Freedom Lite 70914Abbott Diabetes Care Inc · Glucose dehydrogenase, glucose760 reports
- ACCU-CHEK AVIVA PLUS 06908268001Roche Diagnostics Operations, Inc. · Glucose Dehydrogenase, Glucose472 reports
- ACCU-CHEK GUIDE 07453736001Roche Diagnostics Operations, Inc. · Glucose Dehydrogenase, Glucose410 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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