BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 2981993 · Received February 28, 2013

    Report

    Report Number
    3008382007-2013-03900
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    February 2, 2013
    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
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(4) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING A CONTRAST ISSUE ON THE ONETOUCH PING METER. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS OR SEEK ANY MEDICAL ATTENTION BECAUSE OF THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88418 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3316486

    Patients

    Seq Age Sex Outcome Treatment
    1