BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 3141579 · Received June 3, 2013

    Report

    Report Number
    3008382007-2013-14430
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 18, 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
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER ASSOCIATED WITH THIS COMPLAINT HAS BEEN RETURNED TO LIFESCAN; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED LIFESCAN USA ALLEGING A POWER- UNIT POWERS OFF DURING USE ISSUE. THE REPORTER ALLEGED THAT METER ¿SHOWS BLACK SCREEN AND SHUTS OFF¿, BUT ¿ONLY DOES THIS WHEN THE STRIP IS INSERTED INSIDE OF METER¿. THE REPORTER ¿IS ABLE TO TURN METER ON WITH POWER BUTTON AND GO THROUGH NORMAL SETUP¿. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED AT THE TIME OF 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
    245089 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3369796

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR