BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® AVIVA

    MDR report key: 2222205 · Received August 24, 2011

    Report

    Report Number
    1823260-2011-04547
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 24, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S HUSBAND STATES THAT HE ATTEMPTED TO TEST HIS WIFE WITH THE AVIVA METER WHEN SHE WAS UNRESPONSIVE, BUT HE OBTAINED AN ERROR MESSAGE. HUSBAND STATED THE CUSTOMER WAS IN A COMA-LIKE STATE AND THOUGHT THAT IT WAS DUE TO HYPOGLYCEMIA. CUSTOMER DID NOT HAVE ANY OTHER STRIP VIALS WITH WHICH TO TEST AT THE TIME. HUSBAND GAVE CUSTOMER SOME JUICE FOR TREATMENT. HUSBAND THEN CALLED THE AMBULANCE, WHO TRANSPORTED THE CUSTOMER TO THE HOSPITAL DUE TO DEHYDRATION AND LIVER FAILURE. OUTCOME FOR CUSTOMER IS NOT KNOWN. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization