BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 3011972 · Received March 20, 2013

    Report

    Report Number
    3008382007-2013-05627
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Report Date
    February 20, 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
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT METER HAS BEEN RETURNED TO LIFESCAN FOR EVALUATION. THE EVALUATION OF THE METER HAS NOT BEEN COMPLETED; THEREFORE, NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING INACCURATE RESULTS COMPARED TO ANOTHER METER WITH READINGS OF "218MG/DL" VS "55MG/DL" ON AN UNKNOWN METER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED RESULTS DID NOT MEET LIFESCAN¿S ACCURACY/PRECISION 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
    115208 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3209705

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR