BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 2970877 · Received February 21, 2013

    Report

    Report Number
    3008382007-2013-03348
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Report Date
    January 25, 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

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING OBTAINING AN ALLEGED INACCURATE HIGH READING COMPARED TO ANOTHER DEVICE. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF "569 MG/DL" WITH THE SUBJECT METER AND "217 MG/DL" ON ANOTHER DEVICE, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED RESULTS DID NOT MEET LIFESCAN'S ACCURACY CRITERIA AND THE ALLEGED INACCURACY 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
    77179 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3307481

    Patients

    Seq Age Sex Outcome Treatment
    1