BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK INFORM II TEST STRIPS

    MDR report key: 23512177 · Received November 10, 2025

    Report

    Report Number
    1823260-2025-04564
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    October 17, 2025
    Report Date
    December 1, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    UDI-DI
    00365702428102
    PMA / PMN Number
    K121679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDWATCH FIELDS D9 UPDATED. THE ACCU-CHEK INFORM II TEST STRIPS IN THEIR VIAL AND GLUCOSE CONTROLS WERE SUBMITTED FOR INVESTIGATION. THE TEST STRIP VIAL, DESICCANT, AND VIAL CAP WERE INSPECTED AND WERE ACCEPTABLE IN APPEARANCE. THE TEST STRIPS WERE TESTED USING GLYCOLYZED BLOOD. ACCU-CHEK INFORM II TEST STRIPS GLUCOSE INVESTIGATION RESULTS IN MG/DL: 113, 110, 109, 113, 112, 115, 115, 116, 111, 113, 113, 113. GLUCOSE CONTROL INVESTIGATION RESULTS: CONTROL RANGES: LEVEL 1: 30-60 MG/DL LEVEL 2: 261-353 MG/DL RESULTS: LEVEL 1: 46, 46, 45 MG/DL LEVEL 2: 314, 316, 307 MG/DL THE RESULTS USING THE RETURNED TEST STRIPS AND CONTROL WERE ACCEPTABLE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    THE ACCU-CHEK INFORM II METER SERIAL NUMBER WAS NOT PROVIDED. THE CUSTOMER STATED THE QCS WERE ACCEPTABLE WITHIN 24 HOURS OF THE EVENT. THE TEST STRIPS WERE REQUESTED FOR INVESTIGATION, BUT HAVE NOT BEEN RECEIVED AT THIS TIME. IF THEY ARE RETURNED IN THE FUTURE, A FOLLOW-UP REPORT WILL BE SUBMITTED. ON A REGULAR BASIS, INFORM II TEST STRIPS OF LOTS CURRENTLY VALID IN THE MARKET ARE TESTED AS PART OF ROUTINE RETENTION TESTING AND RESULTS HAVE PASSED THE INTERNAL INSPECTION.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION OF A QUESTIONABLE GLUCOSE RESULT FROM ONE PATIENT TESTED WITH THE ACCU-CHEK INFORM II METER + RF METER. AT 11:04 AM, THE METER RESULT WAS 557 MG/DL. AT 11:07 AM, THE METER RESULT WAS 172 MG/DL. THIS RESULT WAS DEEMED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1877906 ACCU-CHEK INFORM II TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS 671736 00365702428102

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Unknown