Accu-Chek Guide 08053723001Recalls & reported problems
Roche Diagnostics Operations, Inc. · Accu-Chek Guide Mail Order 50 ct · 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 blood glucose meter is a home-use device that checks sugar levels with a test strip. The 42 reports mostly describe readings that were wrong or jumped around widely — several users got very different results within minutes of each other from the same meter, and some reported low blood sugar symptoms. There were no deaths and 1 injury. 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
- 42
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00365702726109), received between Dec 17, 2019 and Jun 6, 2025 — classified as 1 injury, 41 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (37 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 Readings37
- High Test Results2
- Imprecise or Erratic Results2
- Therapeutic or Diagnostic Output Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- Hypoglycemia5
- No Consequences Or Impact To Patient5
- No Known Impact Or Consequence To Patient2
- Dizziness1
- Fatigue1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 6, 2025High Test Results; High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 186 MG/DL AT 8:16 AM (GUIDE SYSTEM). 84 MG/DL AT 8:15 AM (AVIVA SYSTEM).
Patient problems: Dizziness
MAUDE report 22156471 ↗MalfunctionNov 1, 2024Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 237 MG/DL AT 11:00 A.M. 125 MG/DL AT 11:01 A.M. 137 MG/DL AT 11:02 A.M. 121 MG/DL AT 11:03 A.M.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20586476 ↗MalfunctionOct 22, 2024High Test Results; High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 350 MG/DL, 139 MG/DL, 224 MG/DL, 196 MG/DL, 124 MG/DL, AND155 MG/DL. THE RESULTS WERE OBTAINED USING TWO DIFFERENT STRIP LOTS, HOWEVER IT IS UNKNOWN WHICH LOT PRODUCED EACH RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20504128 ↗MalfunctionOct 4, 2024Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 44 MG/DL AND 300 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20370749 ↗MalfunctionApr 24, 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: 240 MG/DL, 120 MG/DL, 270 MG/DL AND 140 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19177437 ↗MalfunctionFeb 5, 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: 260 MG/DL AND 101 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18640169 ↗MalfunctionJan 30, 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: 403 MG/DL (SYSTEM 1) AND 130 MG/DL (SYSTEM 2).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18608872 ↗MalfunctionJan 25, 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: 153 MG/DL (SYSTEM 1) AND 80 MG/DL (SYSTEM 2). THE SAME TEST STRIP LOT NUMBER WAS USED FOR BOTH METERS AND RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18580525 ↗MalfunctionDec 20, 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: 50 MG/DL AND 120 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18369249 ↗MalfunctionDec 11, 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: 77 MG/DL, 208 MG/DL AND 128 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18300965 ↗MalfunctionNov 8, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT THE PATIENT RECEIVED A BLOOD GLUCOSE RESULT OF 138 MG/DL AT 3:02 P.M. AND HE EXPERIENCED HYPOGLYCEMIA SYMPTOMS OF FEELING SHAKY, WEAK, AND SWEATY. THE PATIENT WAS UNABLE TO SELF-TREAT AND HIS WIFE PROVIDED GLUCOSE TABLETS, CHOCOLATE MILK, AND SODA. AT 3:16 P.M., THE BLOOD GLUCOSE MONITOR DISPLAYED A RESULT OF 125 MG/DL. THE PATIENT TESTED ON HIS CONTINUOUS GLUCOSE MONITOR AND THE RESULT WAS 58 MG/DL. HIS COMPETITOR METER DISPLAYED A 49 MG/DL RESULT AT THE SAME TIME. THE PATIENT WAS VERY TIRED AND SLEPT FOR A FEW HOURS.
Patient problems: Hypoglycemia
MAUDE report 18094753 ↗MalfunctionJul 26, 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: 226 MG/DL AND 109 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17399184 ↗MalfunctionMay 8, 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: 573 MG/DL AND 200 MG/DL.
Patient problems: Fatigue
MAUDE report 16887788 ↗MalfunctionMay 4, 2023Therapeutic or Diagnostic Output Failure
ACCU-CHEK GUIDE TEST STRIPS STOP WORKING. I'VE GONE THROUGH SEVERAL PACKS WHERE THE TEST STRIPS STOP WORKING 1/2 WAY THROUGH THE PACKAGE.
Patient problems: Insufficient Information
MAUDE report 16877015 ↗MalfunctionApr 4, 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: HI HIGHER THAN THE MEASUREMENT RANGE OF THE METER, HIGHER THAN 600 MG/DL, LO LOWER THAN THE MEASUREMENT RANGE OF THE METER, LOWER THAN 20 MG/DL USING SYSTEM 2 AND 38 MG/DL USING SYSTEM 1.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16673537 ↗MalfunctionMar 16, 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: 235 MG/DL, 506 MG/DL AS WELL AS 506 MG/DL AND 169 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16551135 ↗MalfunctionFeb 7, 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: 367 MG/DL AND 173 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16310451 ↗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: 371 MG/DL AND 130 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15870876 ↗MalfunctionNov 16, 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: 112 MG/DL, "1120 MG/DL", AND 112 MG/DL. THE BLOOD GLUCOSE MONITOR FLASHED TO "1120 MG/DL" AND BACK TO 112 MG/DL A FEW SECONDS LATER FROM THE SAME TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15804190 ↗MalfunctionOct 18, 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: 179 MG/DL (SYSTEM 1), 390 MG/DL (SYSTEM 2) AND 173 MG/DL (SYSTEM 2) . IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 463 MG/DL (SYSTEM 2) AND 218 MG/DL (SYSTEM 2) .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15628688 ↗MalfunctionOct 10, 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: 244 MG/DL AND 118 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15572269 ↗MalfunctionSep 2, 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: "HI" MG/DL (GREATER THAN 600 MG/DL), 48 MG/DL, 70 MG/DL, 66 MG/DL, 52 MG/DL, AND 49 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15349241 ↗MalfunctionJul 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: 421 MG/DL AND 168, MG/DL USING THE GUIDE METER, AS WELL AS 143 MG/DL, USING A SECOND (NON-ROCHE) METER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15122877 ↗MalfunctionJun 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: 92 MG/DL AND LO MG/DL (WHICH ON THE SYSTEM INDICATES A RESULT OF LESS THAN 19 MG/DL)
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14761001 ↗MalfunctionMay 16, 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: 107 MG/DL AND 354 MG/DL. THE CUSTOMER EXPERIENCED SYMPTOMS OF LOW BLOOD GLUCOSE.
Patient problems: Hypoglycemia
MAUDE report 14408928 ↗
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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- 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 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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