BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK INFORM II TEST STRIPS

    MDR report key: 18191888 · Received November 22, 2023

    Report

    Report Number
    1823260-2023-03746
    Event Type
    Malfunction
    Date Received
    November 22, 2023
    Date of Event
    October 31, 2023
    Report Date
    December 13, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    UDI-DI
    00365702428102
    PMA / PMN Number
    K121679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACCU-CHEK INFORM II METER SERIAL NUMBER WAS (B)(6). NO PRODUCT IS EXPECTED TO BE RETURNED. AS NO PRODUCT WAS RETURNED, A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE ACCU-CHEK INFORM II METER SERIAL NUMBER WAS (B)(6). THE STRIPS WERE REQUESTED FOR INVESTIGATION. THE PRODUCT HAS NOT BEEN RECEIVED AT THIS TIME. IF THE PRODUCT IS RETURNED IN THE FUTURE, A FOLLOW-UP REPORT WILL BE SUBMITTED. ON A REGULAR BASIS, ACCU-CHEK INFORM 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

    THE REPORTER COMPLAINED OF DISCREPANT GLUCOSE RESULTS FOR 1 PATIENT'S SAMPLE TESTED ON ACCU-CHEK INFORM II METER COMPARED TO A DIFFERENT ACCU-CHEK INFORM II METER. AT 12:21 PM THE PATIENT WAS TESTED AND GOT A GLUCOSE VALUE OF 49 MG/DL. THE MEDICAL STAFF QUESTIONED THE RESULT AS THEY BELIEVED IT WAS LOW. AT 12:23 PM THE PATIENT WAS THEN TESTED ON ANOTHER METER AND RECEIVED A GLUCOSE VALUE OF 95 MG/DL. PRIOR TO THE EVENT, QC WAS PERFORMED ON THE METER AND IT WAS ACCEPTABLE. AFTER THE EVENT, QC WAS PERFORMED AGAIN ON THE METER USING A DIFFERENT SET OF CONTROLS AND STRIPS. AND IT WAS ALSO ACCEPTABLE. LINEARITY WAS PERFORMED ON THE METER AND IT WAS FOUND TO BE LINEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986266 ACCU-CHEK INFORM II TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS 670235 00365702428102

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown