Accu-Chek Inform II Base Unit 07671717190Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04015630942473), received between Aug 1, 2018 and Nov 23, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Circuit Failure” (4 reports).

3 other recalls cover devices cleared under the same FDA submission (K121679); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 23, 2022Charging Problem; Charging Problem

  THERE WAS AN ALLEGATION OF A BLACKENED CHARGING CONTACT ON AN ACCU-CHEK INFORM II METER CHARGING BASE. THE INITIAL REPORTER ALLEGED THAT THERE ARE NO SIGNS OF MELTED PLASTIC ON THE BASE AND THE METER SHOWS NO SIGNS OF BURNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15854487 ↗
• MalfunctionOct 17, 2022Circuit Failure; Circuit Failure

  THE INITIAL REPORTER COMPLAINED OF AN ISSUE THAT OCCURRED IN THE PAST WITH AN ACCU-CHEK INFORM II BASE UNIT. THE DATE OF THE EVENT IS AN APPROXIMATION; THE REPORTER STATED THE ISSUE OCCURRED ONE YEAR AGO. THE CUSTOMER ALLEGED THE BASE UNIT WAS NOT CHARGING AND THE CHARGING CONTACTS OF THE BASE UNIT APPEARED "SCORCHED" AND "BURNT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15620681 ↗
• MalfunctionOct 17, 2022Circuit Failure; Circuit Failure

  THE INITIAL REPORTER COMPLAINED OF AN ISSUE WITH AN ACCU-CHEK INFORM II BASE UNIT. THE CUSTOMER ALLEGED THE BASE UNIT WAS NOT CHARGING AND THE CHARGING CONTACTS OF THE BASE UNIT APPEARED "SCORCHED" AND "BURNT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15619593 ↗
• MalfunctionOct 17, 2022Circuit Failure; Circuit Failure

  THE INITIAL REPORTER COMPLAINED OF AN ISSUE THAT OCCURRED IN THE PAST WITH AN ACCU-CHEK INFORM II BASE UNIT. THE DATE OF THE EVENT IS AN APPROXIMATION; THE REPORTER STATED THE ISSUE OCCURRED ONE YEAR AGO. THE CUSTOMER ALLEGED THE BASE UNIT WAS NOT CHARGING AND THE CHARGING CONTACTS OF THE BASE UNIT APPEARED "SCORCHED" AND "BURNT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15618775 ↗
• MalfunctionOct 17, 2022Circuit Failure; Circuit Failure

  THE INITIAL REPORTER COMPLAINED OF AN ISSUE THAT OCCURRED IN THE PAST WITH AN ACCU-CHEK INFORM II BASE UNIT. THE DATE OF THE EVENT IS AN APPROXIMATION; THE REPORTER STATED THE ISSUE OCCURRED ONE YEAR AGO. THE CUSTOMER ALLEGED THE BASE UNIT WAS NOT CHARGING AND THE CHARGING CONTACTS OF THE BASE UNIT APPEARED "SCORCHED" AND "BURNT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15618648 ↗
• MalfunctionAug 1, 2018Unauthorized Access to Computer System; Unauthorized Access to Computer System

  AN INTERNAL INVESTIGATION HAS DETERMINED THAT ACCU-CHEK INFORM II BASE UNITS ARE VULNERABLE TO A CYBERSECURITY OR DATA BREACH. THIS WAS DISCOVERED DURING ROCHE INTERNAL INVESTIGATIONS IN CONJUNCTION WITH A CYBERSECURITY CONSULTANT. THE INTERNAL INVESTIGATION DETERMINED THAT SIGNIFICANT PRODUCT AND CYBERSECURITY KNOWLEDGE IS NEEDED TO EXPLOIT THESE VULNERABILITIES. THE CONSULTANT WAS ABLE TO REVERSE ENGINEER THE SERVICE PASSWORD GENERATOR. THE CONSULTANT WAS ALSO ABLE TO EXECUTE CODE THROUGH A HIDDEN COMMAND. THE INVESTIGATION DETERMINED THE FOLLOWING: MODIFICATION OF PROTECTED HEALTH INFORMATION MAY BE POSSIBLE; THE VULNERABILITIES CAN BE EXPLOITED INDEPENDENTLY OR IN COMBINATION. IN THE WORST CASE SCENARIO, THE MEDICAL RISK IS HIGH. THE PROBABILITY OF THIS TYPE OF EVENT OCCURRING IS LOW (CRIMINAL INTENT, THEFT OF THE DEVICE, ENTERING THE FIREWALL, ETC.). THE LIKELIHOOD OF OCCURRENCE OF A SUCCESSFUL ATTACK IS DEEMED LOW TO THEORETICAL WITH INSTALLATIONS SECURED IN ACCORDANCE WITH ROCHE CYBER SECURITY RECOMMENDATIONS. THERE HAVE BEEN NO REPORTS OF ACTUAL OCCURRENCE IN THE FIELD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7740500 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121679. One submission often covers many models, so check the product and lot details in each record.

• Z-2354-2021 · Jul 28, 2021 · Open, Classified
  Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001
• Z-1172-2016 · Feb 11, 2016 · Terminated
  Accu-Chek Inform II Base Unit as a part of the Accu-Chek Inform II Blood Glucose Monitoring System Accu-Chek inform II Blood Glucose Monitoring System is intended for testing outsi
• Z-1113-2013 · Mar 6, 2013 · Terminated
  ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Inform II System to quantitatively measure glucose (sugar).