BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3123435 · Received May 21, 2013

    Report

    Report Number
    3008382007-2013-12593
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    April 25, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Removal / Correction Number
    2013-IE-013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 (LFS) IN THE USA ALLEGING THE METER WAS NOT POWERING ON WHEN THE PATIENT WAS TRYING TO TEST. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING DONE BY THE CUSTOMER CARE ADVOCATE (CCA). THERE WAS NO INDICATION THAT THE LFS PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224046 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3317947

    Patients

    Seq Age Sex Outcome Treatment
    1