BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ACTIVE TEST STRIPS

    MDR report key: 1211380 · Received October 22, 2008

    Report

    Report Number
    1823260-2008-07804
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    October 12, 2008
    Report Date
    October 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K021827
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTEDLY OBTAINED A "HI" (GREATER THAN 600 MG/DL) AND "LO" (LESS THAN 10 MG/DL) ON THE ACCU-CHEK ACTIVE S SYSTEM WITHIN A TEN MINUTE TIMEFRAME. NO REPORTED ACTIONS TAKEN OR TREATMENT RENDERED BASED ON THE 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 22976431

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR METFORMIN - "AWHILE"| POTASSIUM| HUMULIN N - 5 YRS| SINGULAIR| HUMALOG - 5 YRS