BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2981938 · Received February 28, 2013

    Report

    Report Number
    3008382007-2013-03857
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    February 1, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(4) 2013, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING THE METER CASING WAS SPLIT. AT THE TIME OF THE CALL, THE REPORTER MENTIONED THAT THEY NO LONGER HAD THE SUBJECT METER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED METER CASING ISSUE REMAINED UNRESOLVED 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
    88199 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1