BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK INFORM II TEST STRIPS

    MDR report key: 23643672 · Received November 25, 2025

    Report

    Report Number
    1823260-2025-04817
    Event Type
    Malfunction
    Date Received
    November 25, 2025
    Date of Event
    November 3, 2025
    Report Date
    April 21, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    UDI-DI
    00365702428102
    PMA / PMN Number
    K121679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDWATCH FIELD H6 INVESTIGATION CONCLUSION UPDATED.

    Additional Manufacturer Narrative · 0

    MEDWATCH FIELD D9 UPDATED. THE TEST STRIPS WERE RECEIVED FOR INVESTIGATION AND WERE TESTED USING GLYCOLYZED BLOOD. INVESTIGATION RESULTS: GLUCOSE IN MG/DL: 107, 108, 114, 119, 115, 111, 106, 103, 120, 113, 117, 103. THE RESULTS USING THE RETURNED TEST STRIPS WERE ACCEPTABLE, AND NO TEST STRIP DEFECTS WERE OBSERVED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    THE ACCU-CHEK INFORM II METER + RF SERIAL NUMBER IS (B)(6). 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 THE 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. AT 11:40 AM, THE METER RESULT WAS 601 MG/DL OR "HI", AT 11:52 AM, THE LABORATORY RESULT USING A VENOUS SAMPLE WAS 393 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2789614 ACCU-CHEK INFORM II TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS 671669 00365702428102

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Unknown