BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 4861013 · Received June 23, 2015

    Report

    Report Number
    2939301-2015-25752
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Report Date
    May 30, 2015
    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
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT RETURNED ON 06/10/2015 AND TESTED ON 06/22/2015. THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE A DAMAGED DISPLAY. CRACKED/BROKEN LINES WITH BLACK MARKS FOUND ON THE LCD. IN ADDITION A SECONDARY ISSUE WAS NOTED, THE METER WAS FOUND TO HAVE COIL L103 BURNT. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING THERE WERE BLACK MARKS ON THEIR ONETOUCH PING METER DISPLAY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406433 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3685753

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR