BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1161175 · Received September 15, 2008

    Report

    Report Number
    1823260-2008-06888
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE CALLER REPORTS THAT THE CUSTOMER EXPERIENCED AN EVENT WHERE SHE ATTEMPTED TO TEST ON THE ACCU-CHEK AVIVA SYSTEM. THE CUSTOMER RECEIVED A STRIP ERROR. THE CUSTOMER WAS NOT GIVEN HER SCHEDULED NOVOLOG DOSE DUE TO THE INABILITY TO TEST. AROUND ONE HOUR LATER, THE CUSTOMER FELT ILL AND WENT TO A SCHEDULED DIALYSIS APPOINTMENT. THE CUSTOMER'S BLOOD GLUCOSE WAS 386 MG/DL ON THE PROFESSIONAL METER. THE CUSTOMER WAS TREATED WITH INSULIN. THE CUSTOMER'S BLOOD GLUCOSE DECREASED TO 221 MG/DL AND THE CUSTOMER RECEIVED SCHEDULED DIALYSIS TREATMENT. NEW SYSTEM SENT AND RETURN REQUESTED.

    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 300889

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention LANTUS| NOVOLOG