BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ACTIVE TEST STRIPS

    MDR report key: 1080536 · Received July 22, 2008

    Report

    Report Number
    1823260-2008-05664
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K021827
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 1 (LOT NUMBER 22980831, EXPIRATION DATE 6/30/2009). REFERENCE MEDWATCH REPORT FOR THE SUSPECT DEVICE USED IN SYSTEM 2.

    Description of Event or Problem · 1

    REPORTER ALLEGED THAT OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF 65 MG/DL ON ACTIVE SYSTEM 1 COMPARED BACK TO BACK WITH A RESULT OF 120 MG/DL ON THE ACTIVE SYSTEM 2 TESTING WAS PERFORMED WITHIN 10 MINUTES. REPORTER INDICATED THAT HE WAS NOT EXPERIENCING ANY HYPOGLYCEMIC OR HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ACTIVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS-LFR LFR ROCHE DIAGNOSTICS 22980831

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK