BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 3014171 · Received March 21, 2013

    Report

    Report Number
    3008382007-2013-05869
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Report Date
    February 25, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Removal / Correction Number
    2013-IE-005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (CONTROL SOLUTION LOT #): 2AA2G01.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING OBTAINING CONTROL SOLUTION READINGS THAT FELL BELOW THE SPECIFIED CONTROL SOLUTION RANGE PRINTED ON THE VIAL OF TEST STRIPS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED CONTROL SOLUTION 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
    118517 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3371300

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR