BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 5372017 · Received January 16, 2016

    Report

    Report Number
    2939301-2016-02086
    Event Type
    Malfunction
    Date Received
    January 16, 2016
    Report Date
    January 5, 2016
    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
    MA, 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) 2016, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING INACCURATE LOW CONTROL SOLUTION RESULTS. THE USER REPORTED THAT THE QUALITY CONTROL TESTS FAILED SPECIFICATION BECAUSE THE RESULTS FELL BELOW THE SPECIFIED RANGE ON THE TEST STRIP VIAL. THE REPORTER CLAIMED OBTAINING CONTROL SOLUTION READING(S) OF "101 MG/DL" WITH THE CONTROL SOLUTION FOR THE SUBJECT LOT BEING 122-162 MG/DL. 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
    30664 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3702631

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR