BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 4705275 · Received April 20, 2015

    Report

    Report Number
    2939301-2015-15758
    Event Type
    Malfunction
    Date Received
    April 20, 2015
    Report Date
    March 26, 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
    DE, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING INACCURATELY LOW CONTROL SOLUTION RESULTS. THE REPORTER OBTAINED A CONTROL SOLUTION READING OF "116 MG/DL" ON THE SUBJECT METER (ONETOUCH PING). THIS FALLS OUT WITH THE CONTROL SOLUTION RANGE OF "121-161 MG/DL" FOR THIS STRIP LOT. 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
    261766 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3760778

    Patients

    Seq Age Sex Outcome Treatment
    1