BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO METER

    MDR report key: 2933268 · Received January 29, 2013

    Report

    Report Number
    3008382007-2013-01760
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Report Date
    December 12, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K093745
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (03/13/2013)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED ON (B)(4) 2013 AND EVALUATED BY PRODUCT ANALYSIS (PA) ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE REPORTED COMPLAINT WAS OBSERVED ON THE ERROR LOG, HOWEVER, NO MESSAGE WAS OBSERVED DURING CONTROL SOLUTION TESTING. PA WAS UNABLE TO REPRODUCE THE COMPLAINT. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED LIFESCAN (LFS) IN (B)(6) ALLEGING THE METER WAS DISPLAYING AN ERROR 1 MESSAGE. THERE WAS NO INDICATION THAT THE LFS PRODUCT CAUSED OR CONTRIBUTED TO A ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING DONE BY THE CUSTOMER CARE ADVOCATE (CCA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38473 OT VERIO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR