BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 3142024 · Received June 3, 2013

    Report

    Report Number
    3008382007-2013-14497
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 19, 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
    CT, 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) 2013, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING THAT THE SUBJECT METER CONTROL SOLULTION RESULTS READ INACCURATELY. THE REPORTER INDICATED THAT THE METER READINGS WERE "112, 117, 118, AND 119 MG/DL." THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED RESULTS ARE NOT WITHIN LIFESCAN'S CRITERIA. THERE WERE NO ALLEGATIONS OF HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244684 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3432584

    Patients

    Seq Age Sex Outcome Treatment
    1