ACCU-CHEK CONNECT 07250452001Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00365702700017), received between Oct 8, 2020 and Apr 28, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Application Program Problem: Dose Calculation Error” (4 reports).

1 FDA recall record 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 ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2022Application 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. NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14240966 ↗
• MalfunctionNov 24, 2021Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  IT WAS REPORTED THAT THE BOLUS RECOMMENDATIONS PROVIDED BY THE ACCU-CHEK CONNECT APP ARE NOT ACCURATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12869394 ↗
• MalfunctionJul 27, 2021Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  THE CUSTOMER CALLED BACK DAYS AFTER THE ORIGINAL CALL TO ADVISE THAT HE CHANGED THE BATTERIES IN HIS METER OVER THE WEEKEND AND THE BOLUS ADVISOR ON THE APP IS NOW WORKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12233662 ↗
• MalfunctionOct 8, 2020Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  IT WAS REPORTED THAT THE BLOOD GLUCOSE VALUES PROVIDED BY THE CONNECT APP (ANDROID) ARE NOT CORRECT. THE VALUES ARE DISPLAYED WITH TWO DIGITS. IF THE CUSTOMER'S BLOOD GLUCOSE VALUE IS 117 MG/DL, ONLY A VALUE OF 11 MG/DL IS DISPLAYED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10648914 ↗