ACCU-CHEK GUIDE 08053774001Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00365702701908), received between Oct 5, 2022 and May 27, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “High Test Results” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 498 MG/DL AND 41 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088667 ↗
• MalfunctionDec 4, 2024High Test Results; High Test Results

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 181 MG/DL, 184 MG/DL, 185 MG/DL AND 186 MG/DL, TESTED WITH THE PATIENT'S ACCU-CHEK GUIDE METER, AND 89 MG/DL TESTED WITH AN UNKNOWN METER IN THE HOSPITAL AND 98 MG/DL PROVIDED BY THE PATIENT'S DEXCOM SENSOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20846944 ↗
• MalfunctionOct 5, 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: 157 MG/DL (ACCU-CHEK AVIVA METER) AND 90 MG/DL (ACCU-CHEK GUIDE ME METER).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15543303 ↗

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