ACCU-CHEK GUIDE 07453736001Recalls & reported problems
Roche Diagnostics Operations, Inc. · ACCU-CHEK GUIDE 50CT STRIP 36/CS · Class 2
All models of ACCU-CHEK GUIDE (14)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Accu-Chek Guide test strip is used with a meter to measure blood glucose. Its 410 reports mostly describe incorrect or imprecise results, such as two very different readings given to the same patient within minutes. The reports include no deaths and 13 injuries. 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
- 410
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 410 adverse event reports that list this exact device (DI 00365702701953), received between Sep 24, 2019 and Sep 28, 2026 — classified as 13 injuries, 397 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (309 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings309
- Imprecise or Erratic Results45
- High Test Results42
- Low Test Results9
- Adverse Event Without Identified Device or Use Problem2
- Expiration Date Error1
- High Readings1
- Labelling, Instructions for Use or Training Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions267
- No Consequences Or Impact To Patient71
- Hypoglycemia30
- No Known Impact Or Consequence To Patient14
- Hyperglycemia12
- Shaking/Tremors6
- Dizziness4
- Diaphoresis3
Recent adverse event reports
The 25 most recent of 410 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 50917546 ↗MalfunctionApr 16, 2026Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 399 MG/DL AND 131 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24899616 ↗MalfunctionApr 9, 2026Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 210 MG/DL AND 101 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24831145 ↗MalfunctionMar 30, 2026Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: "LO" MG/DL (LESS THAN 20 MG/DL) AND 265 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24714325 ↗MalfunctionMar 19, 2026Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 150 MG/DL, 130 MG/DL, 110 MG/DL, 50 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24637344 ↗MalfunctionMar 11, 2026Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: LO (= LOWER THAN THE MEASUREMENT RANGE OF THE METER) AND 119 MG/DL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24574608 ↗MalfunctionMar 11, 2026Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 275 MG/DL AND 138 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24568458 ↗MalfunctionMar 3, 2026High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 567 MG/DL AND 114 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24495896 ↗MalfunctionFeb 27, 2026Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 442 MG/DL AND 169 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24466494 ↗MalfunctionFeb 27, 2026High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 266 MG/DL AND 120 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24466370 ↗MalfunctionFeb 25, 2026Low Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 80 MG/DL AND 202 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24440243 ↗MalfunctionFeb 24, 2026Low Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 42 MG/DL AND 142 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24427545 ↗InjuryFeb 9, 2026High Test Results
THE PATIENT REPORTED THAT SHE HAD MEASURED HER BLOOD GLUCOSE LEVEL ON (B)(6) 2026 AT 4:45AM IN THE MORNING AND THE RESULT WAS AROUND 276 MG/DL. SHE REPORTED FEELING COLD AT 4:00AM, WHICH IS A PERSONAL SYMPTOM OF LOW BLOOD GLUCOSE, BUT PROCEEDED TO ADMINISTER 5 UNITS OF INSULIN TO TREAT THE HIGH BLOOD GLUCOSE VALUE. LATER THAT MORNING, HER PARTNER PROVIDED FOOD (INCLUDING EGGS AND WATER) IN AN ATTEMPT TO RAISE HER BLOOD GLUCOSE, AS SHE FELT UNABLE TO SELF-TREAT DUE TO HER CONDITION. SHE TOOK A BUS TO THE EMERGENCY ROOM AND ARRIVED AT 11:00AM, A BLOOD GLUCOSE TEST IN THE HOSPITAL SHOWED A RESULT OF 216 MG/DL. SHE WAS RELEASED 50 MINUTES LATER. NO MEDICAL INTERVENTION OR TREATMENT WAS ADMINISTERED DURING THE VISIT.
Patient problems: Hypoglycemia
MAUDE report 24292134 ↗MalfunctionJan 26, 2026High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 302 MG/DL (USER'S METER) AND 130 MG/DL (PROFESSIONAL'S METER).
Patient problems: Dizziness; Headache
MAUDE report 24176992 ↗MalfunctionJan 21, 2026High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 200 MG/DL AND 90 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24130350 ↗MalfunctionJan 16, 2026High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 270 MG/DL, 225 MG/DL, AND 115 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24093605 ↗MalfunctionJan 6, 2026Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 300 MG/DL AND 79 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23979925 ↗MalfunctionDec 23, 2025Low Test Results; Low Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: "LO" MG/DL (LESS THAN 10 MG/DL) AND 181 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23877427 ↗MalfunctionDec 22, 2025Low Test Results; Low Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: LO MG/DL (< 20 MG/DL) AND 137 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23866430 ↗MalfunctionDec 22, 2025Low Test Results; Low Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: LO MG/DL (< 20 MG/DL) AND 184 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23864726 ↗MalfunctionDec 22, 2025Low Test Results; Low Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: LO MG/DL (< 20 MG/DL) AND 102 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23864702 ↗MalfunctionDec 18, 2025Low Test Results; Low Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 21 MG/DL AND 157 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23842467 ↗MalfunctionDec 17, 2025Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 354 MG/DL AND 74 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23828385 ↗MalfunctionNov 17, 2025Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 382 MG/DL, 279 MG/DL, 187 MG/DL, 192 MG/DL AND 177 MG/DL. AT ANOTHER TIME ON THE SAME DAY, THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 379 MG/DL, 232 MG/DL, 187 MG/DL, 192 MG/DL AND 177 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23569532 ↗MalfunctionNov 17, 2025Imprecise or Erratic Results; Imprecise or Erratic Results
DURING A CLINICAL TRIAL IT WAS REPORTED PATIENT 06-006, RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 59 MG/DL AND 204 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23569177 ↗
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 quan
Other Glucose Dehydrogenase, Glucose devices
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- 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 Guide 08256292001Roche Diagnostics Operations, Inc. · Glucose Dehydrogenase, Glucose476 reports
- ACCU-CHEK AVIVA PLUS 06908268001Roche Diagnostics Operations, Inc. · Glucose Dehydrogenase, Glucose472 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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