BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ACTIVE TEST STRIPS

    MDR report key: 1060830 · Received June 16, 2008

    Report

    Report Number
    1823260-2008-04762
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    June 3, 2008
    Report Date
    June 16, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K021827
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTEDLY RECEIVED A 280MG/DL AND 119MG/DL ON THE ACCU-CHEK ACTIVE S SYSTEM WITHIN A 10 MINUTE TIMEFRAME. NO REPORTED SYMPTOMS. THE CUSTOMER TOOK ADDITIONAL FORTAMET DUE TO ERRATIC RESULTS. NO ADVERSE EVENT REPORTED. NEW SYSTEM SENT TO CUSTOMER AND RETURN REQUESTED.

    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 22971831

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR FORTAMET 500MG/DAY 2 YEARS| FUROSEMIDE 20MG/DAY LONG TIME| LISINOPRIL 20MG/DAY LONG TIME| METAMUCIL UNK DOSE - 2X/DAY - LONG TIME| CITRUCEL 630MG/DAY - LONG TIME| IMMODIUM UNK DOSE - 2X/DAY - LONG TIME| MULTIVITAMIN UNK DOSE - 1/DAY- LONG TIME