BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 3933691 · Received July 15, 2014

    Report

    Report Number
    2939301-2014-17401
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Report Date
    July 7, 2014
    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
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCTS FOR EVALUATION. IF THE PRODUCTS ARE RETURNED, LFS WILL EVALUATE THEM AND INFORM THE FDA OF PRODUCTS THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING INACCURATE RESULTS OF 165MG/DL AND 105MG/DL ON (B)(6) 2014 AT 05:49 PM, 190MG/DL AND 138MG/DL ON (B)(6) 2014 AT 09:33 PM AND 98MG/DL AND 125MG/DL ON (B)(6) 2014 AT 12:50 AM WHEN TESTING WITH THE LIFESCAN METER. ALL TESTS WERE PERFORMED WITHIN 20 MINUTES OR LESS OF EACH OTHER. THIS COMPLAINT IS BEING REPORTED BECAUSE BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN¿S CRITERIA FOR PRECISION, 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
    414210 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3535199

    Patients

    Seq Age Sex Outcome Treatment
    1