BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ACTIVE TEST STRIPS

    MDR report key: 1133573 · Received August 22, 2008

    Report

    Report Number
    1823260-2008-06383
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    August 15, 2008
    Report Date
    August 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K021827
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BACK TO BACK BLOOD GLUCOSE RESULTS OF 282 MG/DL, 147 MG/DL AND 130 MG/DL WHEN ALL TESTS WERE PERFORMED WITHIN 10 MINS ON THE ACTIVE S SYSTEM. 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 22980931

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK