BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1033160 · Received April 23, 2008

    Report

    Report Number
    1823260-2008-03458
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    April 16, 2008
    Report Date
    April 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN INCIDENT OF HYPOGLYCEMIA REQUIRING PROFESSIONAL MEDICAL TREATMENT. CUSTOMER REPORTED METER RESULT OF 141 MG/DL ON THE AVIVA SYSTEM AND 56 MG/DL WITHIN 10 MINUTES ON EMT'S METER. A REQUEST WAS MADE FOR THE RETURN OF THE SYSTEM, REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 300949

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR CALCITRIOL - 0.25MCG/1/DAY| WARFARIN SODIUM - 2.5MG/DAY| "ISOSORDIDEMIN" - 6MG/2/DAY| LEXIPRO - 10MG/1/DAY| HYDRALAZINE - 25MG/2/DAY| SIMVASTATIN - 20MG/DAY| "PANTOPRAZOLESOD" - 40MG/DAY| "ZOLPHIDEMTARTARTE" - 5MG/DAY| PLAVIX - 75MG/DAY| CARVEDILOL - 6.25MG/2/DAY| LANTUS - 5 UNITS/PM| NOVOLOG SLIDING SCALE| LANTUS - 5 UNITS/AM| FUROSEMIDE - 80MG/2/DAY| FEXOFENADINE HCL - 60MG/2/DAY| FLOMAX - 0.4MG/DAY