BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK AVIVA

    MDR report key: 1242992 · Received November 21, 2008

    Report

    Report Number
    1823260-2008-08690
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    November 6, 2008
    Report Date
    November 21, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    NBW
    PMA / PMN Number
    K043474
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN INCIDENT OF HYPERGLYCEMIA REQUIRING HOSPITALIZATION AFTER HE HAD ATTEMPTED AND WAS UNABLE TO USE HIS AVIVA SYSTEM WITHIN 24 HOURS BEFORE THE INCIDENT DUE TO AN ERROR WITHIN SPECIFICATIONS. AT A SCHEDULED DOCTOR'S APPOINTMENT, CUSTOMER'S BLOOD GLUCOSE WAS 630 MG/DL ON THE DOCTOR'S METER, DOCTOR ADMITTED CUSTOMER TO HOSPITAL. THE CUSTOMER STATED HE HAD BEEN GETTING THE ERROR FOR 3 DAYS PRIOR TO THE APPOINTMENT. A REQUEST WAS MADE FOR THE RETURN OF THE SYSTEM AND A REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK AVIVA BLOOD GLUCOSE MONITORING DEVICE - NBW NBW ROCHE DIAGNOSTICS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization "POTASSIVE"| PERCOCET| "FORMETHAVINE"| HUMALIN N AND R 80/35 SCALE| LOPRESSOR| "NORVAN"| LIPITOR