BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 2932029 · Received January 28, 2013

    Report

    Report Number
    2939301-2013-00003
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    September 26, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER FAILED TESTING, BUT THE ERROR WAS NOT REPRODUCIBLE. A SECONDARY ISSUE WAS FOUND WHICH WAS UNRELATED TO THE COMPLAINT, THE CASING PAINT WAS DAMAGED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A SECOND FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED LIFESCAN (LFS) IN THE USA ALLEGING THE METER WAS DISPLAYING AN ERROR 1 MESSAGE. THERE WAS NO INDICATION THAT THE LFS PRODUCT CAUSED OR CONTRIBUTED TO A ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING DONE BY THE CUSTOMER CARE ADVOCATE (CCA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38342 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR