BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 2860900 · Received December 6, 2012

    Report

    Report Number
    3008382007-2012-07354
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Report Date
    November 20, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS REPLACED AND REQUESTED BACK FOR INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED LFS ALLEGING THAT THE METER WOULD NOT POWER ON. THE PATIENT DENIED EXHIBITING ANY SYMPTOMS OR SEEKING ANY MEDICAL ATTENTION DUE TO THE REPORTED ISSUE. THE PATIENT WAS USING THE CORRECT TEST STRIPS. THERE WAS NO MISUSE OF THE PRODUCT. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE ALLEGED ISSUE WAS NOT RESOLVED OVER THE PHONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3374188

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR