BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1772044 · Received November 2, 2007

    Report

    Report Number
    1823260-2007-09542
    Event Type
    Malfunction
    Date Received
    November 2, 2007
    Date of Event
    October 4, 2007
    Report Date
    November 2, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    REPORTER STATED THAT PATIENT'S BLOOD GLUCOSE WAS MEASURED TWICE, USING THE AVIVA SYSTEM, WITH RESULTS OF 300 MG/DL AND 300 MG/DL. REPORTER INDICATED THAT PATIENT WAS EXHIBITING SYMPTOMS OF HYPOGLYCEMIA. PATIENT'S BLOOD GLUCOSE WAS REPORTEDLY RETESTED, ON A DIFFERENT DEVICE, WITH A RESULT OF <50 MG/DL. REPORTER INDICATED THAT PATIENT WAS TREATED, BY HIS MOTHER, WITH "GLUCOSPORT" AND MILK. TEN MINUTES LATER, PATIENT REPORTEDLY EXPERIENCED CONVULSIONS. AN UNSPECIFIED TIME LATER, PATIENT WAS REPORTEDLY TAKEN TO THE HOSPITAL AND TREATED WITH "ENDOVENOUS GLYCOSYLATED SERUM." NO ADDITIONAL INFORMATION ABOUT TREATMENT RECEIVED WAS PROVIDED. THE MANUFACTURER REQUESTED THE RETURN OF THE SUSPECT PRODUCTS FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS 300174

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK