ACCU-CHEK GUIDE 07453701001Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00365702701977), received between Feb 3, 2020 and Jul 7, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (9 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.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 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 189 MG/DL ON THE ACCU-CHEK GUIDE BLOOD GLUCOSE MONITOR. THIS RESULT IS CONSIDERED LOW FOR THE PATIENT AS HER NORMAL BLOOD GLUCOSE RESULT IS AROUND 200 MG/DL. THE PATIENT TESTED ON HER TANDEM INSULIN PUMP A MINUTE LATER, AND THE BLOOD GLUCOSE RESULT WAS 300 MG/DL. THE PATIENT EXPERIENCED SYMPTOMS OF NAUSEA AND WEAKNESS, SO SHE HAD A FRIEND TAKE HER TO THE HOSPITAL, WHICH IS AROUND 45 MINUTES AWAY FROM HER HOUSE. THE PATIENT WAS TREATED WITH AN UNKNOWN IV AT THE HOSPITAL. THE BLOOD GLUCOSE RESULTS AT THE HOSPITAL WERE NOT PROVIDED. THE PATIENT WAS ADMITTED INTO THE HOSPITAL UNTIL (B)(6) 2023.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 17280210 ↗
• 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: 375 MG/DL (GUIDE SYSTEM) AND 115 MG/DL (PROFESSIONAL SYSTEM).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16674064 ↗
• MalfunctionSep 7, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER ALLEGEDLY RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT METERS, WITHIN 15 MINUTES: 112 MG/DL (SYSTEM 1), 222 MG/DL (SYSTEM 2), AND 115 MG/DL (SYSTEM 2).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12436423 ↗
• MalfunctionMay 20, 2021Incorrect, 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: 316 MG/DL (SYSTEM 1) AND 142 MG/DL (SYSTEM 2).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11857017 ↗
• MalfunctionApr 19, 2021Incorrect, 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: 104 MG/DL AND 460 MG/DL. THE PATIENT SELF-TREATED WITH INSULIN DUE TO ELEVATED BLOOD GLUCOSE RESULT.

  Patient problems: Hyperglycemia

  MAUDE report 11685189 ↗
• MalfunctionMar 17, 2021Incorrect, 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 (AVIVA) AND 134 MG/DL (GUIDE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11506895 ↗
• MalfunctionJun 29, 2020Incorrect, 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: 0.8 MMOL/L AND 70 MMOL/L.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10205731 ↗
• MalfunctionJun 23, 2020Incorrect, 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: 257 MG/DL, 660 MG/DL AND 651 MG/DL. THE PATIENT USED 2 LOTS OF STRIPS AND WAS UNSURE WHICH STRIPS PROVIDED WHICH RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10185705 ↗
• MalfunctionFeb 3, 2020Incorrect, 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: 86 MG/DL, 160 MG/DL, 164 MG/DL, A RESULT IN THE "90'S MG/DL", AND 116 MG/DL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9660224 ↗

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, Classified
  Accu-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 · Terminated
  Blood 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