BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK AVIVA

    MDR report key: 1163589 · Received September 17, 2008

    Report

    Report Number
    1823260-2008-06952
    Event Type
    Injury
    Date Received
    September 17, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 17, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    NBW
    PMA / PMN Number
    K043474
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DUE TO NO POWER IN HER AVIVA METER, SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE ON THE MORNING OF A ROUTINE CHECKUP AT HER HOSPITAL, REQUIRING PROFESSIONAL MEDICAL TREATMENT. HER LAST SUCCESSFUL TEST WAS AT 9:00 AM THE PREVIOUS MORNING. SHE REPORTED SHE DID NOT EAT AS USUAL OR TAKE HER ROUTINE DIABETES MEDICATIONS THE MORNING OF THE APPOINTMENT BECAUSE SHE COULD NOT TEST. AT HER CHECKUP, THE DR GAVE HER INSULIN. A REQUEST WAS MADE FOR THE RETURN OF THE PRODUCT, REPLACEMENT 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 59 YR Required Intervention HUMALOG SLIDING SCALE| LEVEMIR SLIDING SCALE