ACCU-CHEK CONNECT 07562462001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00365702700000), received between Feb 3, 2020 and Dec 30, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Application Program Problem: Dose Calculation Error” (2 reports).

2 FDA recall records name this device's identifier.

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.

Recalls naming this device

1. Dec 20, 2016Class IITerminated

   iOS and Android: Under certain conditions the affected app versions may disregard historical bolus data potentially leading to an incorrect bolus insulin recommendation being provided to the user. iOS only: Pairing and using multiple meters with the Accu-Chek Connect app can under rare circumstances cause the bolus advisor to fail to offer a correction bolus recommendation within the eligible time window following a blood glucose measurement (10 15 minutes). Depending on the individual metabolic situation potentially incorrect bolus advice could lead to serious health consequences such as hypoglycemia. Both software issues may also cause the amount of active insulin displayed during the bolus calculation process to be incorrect and should not be used to manually calculate a bolus.

   Z-1099-2017 · Root cause: Software design · Recall details · FDA record ↗

2. Sep 14, 2016Class IITerminated

   Roche Diabetes Care, Inc. initiated a voluntary recall for the version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS), released on July 11, 2016, due to the software containing a programming error (bug) in the Bolus Advisor feature, which could lead to an incorrect insulin bolus recommendation.

   Z-0586-2017 · Root cause: Software design (manufacturing process) · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2020Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  IT WAS REPORTED THAT THE BOLUS RECOMMENDATIONS PROVIDED BY THE BOLUS ADVICE APP ARE NOT ACCURATE. BACKUP FILES ARE NOT AVAILABLE TO BE SENT FOR EVALUATION. THE CONNECT APP (VERSION 2.1.9.1), IS NOT COMPATIBLE WITH THE CUSTOMER'S PHONE (IOS VERSION 14 OR IPHONE 12 MAX).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11094798 ↗
• MalfunctionFeb 3, 2020Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  IT WAS REPORTED THAT THE BOLUS RECOMMENDATIONS PROVIDED BY THE BOLUS CALCULATOR ARE NOT ACCURATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9661082 ↗