BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESCAN

    MDR report key: 491506 · Received October 3, 2003

    Report

    Report Number
    MW1029807
    Event Type
    Malfunction
    Date Received
    October 3, 2003
    Date of Event
    September 30, 2003
    Report Date
    September 30, 2003
    Manufacturer
    LIFESCAN
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT. REPORTS RECEIVING LOW READINGS WITH ONE TOUCH ULTRA TEST STRIPS FROM LOT 1022857 WITH EXP 11/04 AND CODE 15. PT WAS HAVING CONSISTENTLY LOW READINGS AND WAS INCREASING SUGAR INTAKE TO COMPENSATE. AFTER RECEIVING A READING OF 35 BECAME SUSPICIOUS OF DEFECT, TESTED IMMEDIATELY WITH A STRIP OF LOT #1022462 WITH EXP. 10/04 CODE 8 AND RECEIVED A RESULT OF 110. PT. ALSO DID CHECK MACHINE WITH CONTROL SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESCAN ONE TOUCH ULTRA CFR LIFESCAN * 1022857

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other