BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 3233237 · Received July 18, 2013

    Report

    Report Number
    3008382007-2013-20184
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    July 8, 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
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING THE METER WAS DISPLAYING A "PC" SYMBOL WITHOUT BEING CONNECTED TO THE COMPUTER. THE REPORTER STATED THE PATIENT HAD SYMPTOMS OF "NAUSEA" PRIOR TO THE START OF THE ALLEGED ISSUE ON (B)(6) 2013, AT 3PM. THE REPORTER DENIED THE PATIENT RECEIVING ANY MEDICAL TREATMENT IN RESPONSE TO THE ALLEGED SYMPTOMS. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THE PATIENT'S REPORTED SYMPTOMS DO NOT MEET LFS' CRITERIA FOR A SERIOUS INJURY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334616 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3421600

    Patients

    Seq Age Sex Outcome Treatment
    1