BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 3051918 · Received April 11, 2013

    Report

    Report Number
    3008382007-2013-07544
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Report Date
    March 16, 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
    GA, 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

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THAT THE CONTROL SOLUTION RESULTS WERE BELOW THE EXPECTED CONTROL SOLUTION RANGE. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156776 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3400000

    Patients

    Seq Age Sex Outcome Treatment
    1