Accu-Chek Guide 07398794001Recalls & reported problems
Roche Diagnostics Operations, Inc. · ACCU-CHEK GUIDE MG/DL METER 923 (US) · Class 2
All models of ACCU-CHEK GUIDE (14)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is the Accu-Chek Guide blood glucose meter, a home testing device that measures sugar in a drop of blood. The 61 reports mostly describe the screen showing the wrong unit of measurement, mmol/L instead of mg/dL, along with meters that would not power up and hard-to-read or flashing displays. Seven reports describe injuries and there are no deaths. No recalls name this device, and reports have dropped sharply, from 8 in the prior 12 months to none in the last 12 months.
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
- 61
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 00365702609105), received between Feb 24, 2020 and Jul 29, 2025 — classified as 7 injuries, 54 malfunctions.
The most frequently reported specific device problem is “Display or Visual Feedback Problem” (49 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
- Display or Visual Feedback Problem49
- Adverse Event Without Identified Device or Use Problem4
- Display Difficult to Read2
- Failure to Power Up2
- Flare or Flash1
- Incorrect, Inadequate or Imprecise Result or Readings1
- Insufficient Device Problem Information1
- Sparking1
Patient problems
- No Clinical Signs, Symptoms or Conditions53
- Hypoglycemia4
- Hyperglycemia2
- Elevated Ketones/ Diabetic Ketoacidosis1
- Headache1
- Heart Failure/Congestive Heart Failure1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 29, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE UNIT OF MEASURE ON THE BLOOD GLUCOSE MONITOR WAS DISPLAYED IN MMOL/L (FOR EXAMPLE, 8.3). THE UNIT OF MEASURE ON THE BACK OF THE METER IS IN MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22640940 ↗MalfunctionFeb 19, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE BLOOD GLUCOSE MONITOR WAS LABELED WITH AN INCORRECT UNIT OF MEASURE. THE METER WAS SUPPOSEDLY READING IN MMOL/L INSTEAD OF MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21408229 ↗InjuryJan 3, 2025Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT THE BLOOD GLUCOSE MONITOR WAS UNAVAILABLE FOR USE DUE TO POWER CONCERNS. THE POWER ISSUE ON THE METER STARTED THE DAY PRIOR TO THE EVENT, THEREFORE THE USER WAS UNABLE TO TEST. IT WAS REPORTED THAT THE CUSTOMER TOOK ALL OF HER MEDICATIONS AS NORMAL, EXCEPT HER NOVOLOG INSULIN, PRIOR TO THE EVENT. THE USER REPORTED THAT HER NOVOLOG INSULIN IS ON A SLIDING SCALE BASED ON HER BLOOD GLUCOSE RESULT, AND SINCE SHE WAS UNABLE TO TEST, SHE WITHHELD HER NOVOLOG. ON THE MORNING OF THE INCIDENT AT APPROXIMATELY 6:00AM, THE CUSTOMER EXPERIENCED A SEVERE HEADACHE. AT 7:00AM SHE ATTEMPTED TO TEST ON HER GUIDE METER AND IT STILL DID NOT HAVE POWER. THE USER'S DAUGHTER CALLED THE EMT'S. UPON ARRIVAL, THE EMT'S RECEIVED A BLOOD GLUCOSE RESULT OF 427 MG/DL ON THEIR PROFESSIONAL METER. THE USER WAS TREATED WITH OXYGEN AND 18 UNITS OF NOVOLOG. THE EMT'S STAYED WITH THE CUSTOMER FOR 30-45 MINUTES, UNTIL SHE RECOVERED. THE USER WAS ONLY TREATED AT HOME AND WAS NOT TRANSPORTED TO THE HOSPITAL.
Patient problems: Headache
MAUDE report 21069082 ↗MalfunctionDec 12, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE BLOOD GLUCOSE MONITOR DISPLAYED THE INCORRECT UNIT OF MEASURE FOR WHICH IT WAS LABELED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20918467 ↗MalfunctionDec 12, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE BLOOD GLUCOSE MONITOR DISPLAYED THE INCORRECT UNIT OF MEASURE FOR WHICH IT WAS LABELED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20915473 ↗MalfunctionNov 27, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE BLOOD GLUCOSE MONITOR WAS READING IN THE INCORRECT UNIT OF MEASURE FOR WHICH IT IS LABELED. THE CUSTOMER COULD NOT BE REACHED FOR ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20798565 ↗MalfunctionNov 14, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THE PATIENT RECEIVED THE BLOOD GLUCOSE MONITOR IN THE WRONG UNIT OF MEASURE. THE CONFIGURED UNIT OF THE METER IS MMOL/L BUT THE UNIT ON THE LABEL IS MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20683233 ↗MalfunctionNov 5, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE BLOOD GLUCOSE MONITOR DISPLAYED THE INCORRECT UNIT OF MEASURE FOR WHICH IT WAS LABELED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20608421 ↗MalfunctionOct 15, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE BLOOD GLUCOSE MONITOR WAS READING IN THE INCORRECT UNIT OF MEASURE FOR WHICH IT IS LABELED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20457630 ↗MalfunctionSep 16, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE BLOOD GLUCOSE MONITOR DISPLAYED THE INCORRECT UNIT OF MEASURE FOR WHICH IT WAS LABELED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20226522 ↗MalfunctionSep 11, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE BLOOD GLUCOSE MONITOR WAS READING IN THE INCORRECT UNIT OF MEASURE FOR WHICH IT IS LABELED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20189229 ↗MalfunctionAug 28, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE BLOOD GLUCOSE MONITOR DISPLAYED A RESULT IN MMOL/L INSTEAD OF MG/DL. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20086694 ↗MalfunctionAug 23, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE USER REPORTED THE SERIAL NUMBER OF HER DEVICE WAS LISTED IN THE RECALL LETTER FOR THE BLOOD GLUCOSE MONITOR READING IN THE INCORRECT UNIT OF MEASURE. THE USER DISCARDED THE DEVICE AND COULD NOT PROVIDE ANY INFORMATION OFF OF THE BACK LABEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20046814 ↗MalfunctionAug 22, 2024Display Difficult to Read; Display Difficult to Read
IT WAS REPORTED THAT THE BLOOD GLUCOSE MONITOR WAS READING IN THE INCORRECT UNIT OF MEASURE FOR WHICH IT IS LABELED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20039504 ↗MalfunctionAug 15, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE UNIT OF MEASURE WAS INCORRECT ON THE BLOOD GLUCOSE MONITOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19995330 ↗MalfunctionAug 15, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE BLOOD GLUCOSE MONITOR WAS READING IN THE INCORRECT UNIT OF MEASURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19995182 ↗MalfunctionAug 9, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE BLOOD GLUCOSE MONITOR WAS READING IN THE INCORRECT UNIT OF MEASURE FOR WHICH IT IS LABELED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19952803 ↗MalfunctionAug 6, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED, THAT THE BLOOD GLUCOSE MONITOR WAS READING IN THE INCORRECT UNIT OF MEASURE. FOR WHICH, IT IS LABELED. THE METER WAS READING IN MMOL/L INSTEAD OF MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19919350 ↗MalfunctionAug 6, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE BLOOD GLUCOSE MONITOR WAS READING IN THE INCORRECT UNIT OF MEASURE FOR WHICH IT IS LABELED. THE METER WAS READING IN MMOL/L INSTEAD OF MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19917265 ↗MalfunctionAug 6, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE BLOOD GLUCOSE MONITOR WAS READING IN THE INCORRECT UNIT OF MEASURE FOR WHICH IT IS LABELED. THE METER WAS READING IN MMOL/L INSTEAD OF MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19917260 ↗MalfunctionAug 6, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE BLOOD GLUCOSE MONITOR WAS READING IN THE INCORRECT UNIT OF MEASURE FOR WHICH IT IS LABELED. THE METER WAS READING IN MMOL/L. BASED ON THE SERIAL NUMBER, THE BLOOD GLUCOSE MONITOR SHOULD BE READING IN MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19917259 ↗MalfunctionAug 6, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE BLOOD GLUCOSE MONITOR WAS READING IN THE INCORRECT UNIT OF MEASURE FOR WHICH IT IS LABELED. THE METER WAS READING IN MMOL/L INSTEAD OF MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19917244 ↗MalfunctionAug 6, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE BLOOD GLUCOSE MONITOR WAS READING IN THE INCORRECT UNIT OF MEASURE FOR WHICH IT IS LABELED. THE METER WAS READING IN MMOL/L INSTEAD OF MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19917235 ↗MalfunctionAug 6, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE BLOOD GLUCOSE MONITOR WAS READING IN THE INCORRECT UNIT OF MEASURE FOR WHICH IT IS LABELED. THE METER WAS READING IN MMOL/L INSTEAD OF MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19917228 ↗MalfunctionAug 6, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE BLOOD GLUCOSE MONITOR WAS READING IN THE INCORRECT UNIT OF MEASURE FOR WHICH IT IS LABELED. THE METER WAS READING IN MMOL/L INSTEAD OF MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19917216 ↗
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 System, Test, Blood Glucose, Over The Counter devices
- OneTouch Verio Flex 023-271LifeScan Europe GmbH · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER3,703 reports
- FreeStyle Libre 2 71953Abbott Diabetes Care Inc · System, test, blood glucose, over the counter2 recalls1 death3,286 reports
- OneTouch Ultra2 021-105LifeScan U.S. LLC · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER1,731 reports
- Omnipod DASH PDM PDM-USA1-D001-MG-USA1Insulet Corporation · System, Test, Blood Glucose, Over The Counter1 recall10 deaths1,129 reports
- Omnipod UST400Insulet Corporation · System, Test, Blood Glucose, Over The Counter12 deaths816 reports
- TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER - NOT FOR RETAIL SALETrividia Health, Inc. · System, Test, Blood Glucose, Over The Counter418 reports
- FreeStyle Freedom Lite 70923-70Abbott Diabetes Care Inc · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER378 reports
- FreeStyle Lite 70829-70Abbott Diabetes Care Inc · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER378 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 13, 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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