Accu-Chek Inform II Instrument with RF card 04882458001Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04015630945757), received between Dec 13, 2021 and Aug 15, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Display Difficult to Read” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2022Circuit Failure; Charging Problem; Circuit Failure; Charging Problem

  THERE WAS AN ALLEGATION OF BLACKENED CHARGING CONTACTS ON THE BASE UNIT OF THE ACCU-CHEK INFORM II METER DOCKING STATION. IT WAS REPORTED THAT THERE WERE NO SIGNS OF MELTED PLASTIC ON THE BASE OR ANY DAMAGE WITH THE METERS DOCKED IN THE BASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15226665 ↗
• MalfunctionJun 21, 2022Patient Data Problem; Patient Data Problem

  THERE WAS AN ALLEGATION OF AN INCORRECT DATE BEING TRANSMITTED FROM THE ACCU-CHEK INFORM II METER TO THE COBAS INFINITY SYSTEM. ON (B)(6) 2022, THE PATIENT WAS MEASURED WITH THE ACCU-CHEK INFORM II METER. THE CUSTOMER REVIEWED THE GLUCOSE RESULT WITHIN THE INFINITY SYSTEM AND THE DATE OF THE RESULT STATED (B)(6) 2022. THE METER WAS RESET AND RESTARTED, THE CUSTOMER CONFIRMED THE VALUE TO THE COBAS INFINITY SYSTEM WAS (B)(6) 2022. THE CUSTOMER CONFIRMED THE PATIENT'S RESULT WAS FROM (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14752301 ↗
• MalfunctionMar 8, 2022Display Difficult to Read; Image Display Error/Artifact; Display Difficult to Read; Image Display Error/Artifact

  THERE WAS AN ALLEGATION OF A DISPLAY ISSUE WITH AN ACCU-CHEK INFORM II METER, WHICH LED TO A GLUCOSE RESULT MISINTERPRETATION AND AN INCORRECT INSULIN DOSAGE. IT WAS REPORTED THAT THE METER WAS NOT DAMAGED, BUT THERE WERE BLACK SPLOTCHES ON THE SCREEN AND IN THE RESULTS FIELD. THE CUSTOMER PERFORMED A METER RESET BUT THE ISSUE PERSISTED. THE CUSTOMER REPORTED THAT A METER GLUCOSE RESULT WAS MISINTERPRETED, 280 MG/DL INSTEAD OF 230 MG/DL. THE PATIENT'S NURSE PROVIDED THE INCORRECT INSULIN DOSAGE. THE CUSTOMER DID NOT KNOW HOW MUCH INSULIN OR WHAT KIND OF INSULIN WAS PROVIDED TO THE PATIENT, THE INFORMATION WAS REQUESTED BUT NOT PROVIDED. IT WAS REPORTED THE PATIENT WAS "FINE" AND "THERE WAS NOT ANY HARM OR INJURY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13692933 ↗
• MalfunctionDec 13, 2021Display Difficult to Read; Image Display Error/Artifact; Display Difficult to Read; Image Display Error/Artifact

  THERE WAS A COMPLAINT OF MISTAKEN GLUCOSE RESULTS DUE TO A PIXELATED DISPLAY AFFECTING TWO PATIENTS TESTED WITH AN ACCU-CHEK INFORM II METER. PATIENT 1¿S RESULT FROM THE METER AT 7:56 AM WAS MISTAKEN FOR 136 MG/DL. THE CUSTOMER VERIFIED THE INITIAL METER READING FROM THE SOFTWARE AS 183 MG/DL. PATIENT 2¿S RESULT FROM THE METER AT 9:30 AM WAS MISTAKEN FOR 186 MG/DL. THE CUSTOMER VERIFIED THE INITIAL METER READING FROM THE SOFTWARE AS 136 MG/DL. THE CUSTOMER USED TEST STRIPS LOT NUMBER 480036 AND THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12982945 ↗

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).