BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1011806 · Received March 11, 2008

    Report

    Report Number
    1823260-2008-02297
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 25, 2008
    Report Date
    March 11, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 PT OBTAINED BACK-TO-BACK BLOOD GLUCOSE RESULTS OF 470 MG/DL AND 120-140 MG/DL (EXACT VALUE NOT PROVIDED) WHILE USING THE AVIVA SYSTEM. REPORTER DID NOT INDICATE IF PT MODIFIED THERAPY BASED ON THESE VALUES. NO ADVERSE EVENT WAS REPORTED. THE MFR 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 LFR ROCHE DIAGNOSTICS 200870

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK