BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 4171901 · Received October 15, 2014

    Report

    Report Number
    2939301-2014-27567
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Report Date
    October 12, 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
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) 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 LOW RESULTS COMPARED TO ANOTHER DEVICE. THE REPORTER REPORTED OBTAINING BLOOD GLUCOSE READINGS OF "128 MG/DL" WITH THE SUBJECT METER AND "300, 219 AND 207 MG/DL" WITH ANOTHER DEVICE. THE TESTS WERE 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
    655830 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3518630

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR