BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE STRIPS

    MDR report key: 685220 · Received March 1, 2006

    Report

    Report Number
    1823260-2006-00948
    Event Type
    Malfunction
    Date Received
    March 1, 2006
    Date of Event
    January 30, 2006
    Report Date
    January 30, 2006
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFANT WAS TESTED WITH INFORM UJ40007459 WITH A RESULT OF LO AT 1:35PM AND A RESULT OF 11MG/DL AT 1:15PM. APPROX. AN HOUR LATER, CALLER REPORTS TRYING TO TEST THE INFANT BUT OBTAINED ERROR 83 ON 3 DIFFERENT INFORM DEVICES: UJ40007459, UJ48010973, AND UJ40007463. CALLER STATES THE POCC RAN CONTROLS ON THE DEVICE AND THEY FUNCTIONED NORMALLY AND FELL WITHIN ACCEPTABLE DUE TO ERROR 83'S, CUREENT INFORM MANUAL: 03034968001-05 0604 INDICATES THAT ERROR 83 CAN BE DUE TO EXTREMELY LOW BLOOD GLUCOSE, BELOW METER'S READING RANGE OR THAT THE TEST STRIP MAY BE DEFECTIVE. REQUESTED RETURN OF ALL 3 SUSPECT DEVICES AND CALLER DECLINED REPLACEMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE STRIPS BLOOD GLUCOSE MONITORING CFR ROCHE DIAGNOSTICS NA 548536

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY