BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® AVIVA

    MDR report key: 2223584 · Received August 25, 2011

    Report

    Report Number
    1823260-2011-04580
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 17, 2011
    Report Date
    October 13, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES THAT HE ATTEMPTED TO TEST ON HIS AVIVA METER, BUT OBTAINED AN ERROR MESSAGE, WHEN HE WAS FEELING SYMPTOMS OF HYPERGLYCEMIA. CUSTOMER TOOK LOSARTAN 50 MG AND 2 TABLETS OF SOMA BEFORE OBTAINING THE READINGS. CUSTOMER FELT WEAK, SO HIS FRIEND DROVE HIM TO THE HOSPITAL. CUSTOMER WAS TESTED AT "A LITTLE OVER 500 MG/DL" ON THE HOSPITAL METER WHEN HE ARRIVED. CUSTOMER WAS TREATED WITH "A QUICK ACTING SHOT TO LOWER HIS BLOOD SUGAR" AND RELEASED FROM THE HOSPITAL. 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
    1 074 YR Required Intervention PRILOSEC| NOVOLOG| SOMA| CELEXA 1X DAILY| FORADIL 2X DAILY| ZOCOR 1X DAILY