BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1070106 · Received July 3, 2008

    Report

    Report Number
    1823260-2008-05163
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    April 8, 2008
    Report Date
    July 3, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN ANOTHER COUNTRY.

    Description of Event or Problem · 1

    REPORTER STATED THAT PATIENT OBTAINED BACK-TO-BACK BLOOD GLUCOSE RESULTS OF 19.9 MMOL/L AND 3.6 MMOL/L ON THE AVIVA SYSTEM. REPORTER DID NOT INDICATE IF PATIENT MODIFIED THERAPY BASED ON THESE VALUES. NO ADVERSE EVENT WAS REPORTED. THE MANUFACTURER REQUESTED THE RETURN OF THE SUSPECT PRODUCT AND REPLACEMENT PRODUCT WAS SHIPPED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK