BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ACTIVE TEST STRIPS

    MDR report key: 1040947 · Received May 2, 2008

    Report

    Report Number
    1823260-2008-03716
    Event Type
    Malfunction
    Date Received
    May 2, 2008
    Date of Event
    March 1, 2008
    Report Date
    May 2, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Description of Event or Problem · 1

    CALLER STATES THE PT TESTED APPROX 300MG/DL AND APPROX 30MG/DL ON THE AVIVA SYSTEM WITHIN 10 MINUTES. CUSTOMER WAS GIVEN AN IV TO DILUTE THE BLOOD GLUCOSE BUT THE IV WAS DISCONTINUED ONCE THE RESULT OF APPROX 30MG/DL WAS OBTAINED. NO ADVERSE EVENT REPORTED DUE TO ADMINISTRATION OF THE IV. REQUESTED RETURN OF SUSPECT SYSTEM, HOWEVER, STRIPS ARE UNAVAILABLE FOR RETURN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK