BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3020431 · Received March 26, 2013

    Report

    Report Number
    3008382007-2013-06181
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (06/17/2013)-DEVICE EVALUATION: THE ANALYSIS OF THE SUBJECT METER WAS COMPLETED ON (B)(6) 2013 BY LIFESCAN PRODUCT ANALYSIS. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THE DEVICE MET ALL SPECIFICATIONS FOR TESTING AND NO SOURCES OF HIGH SLEEPING MODE CURRENT WERE OBSERVED DURING INVESTIGATION. THE METER DEMONSTRATED NORMAL FUNCTIONS. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    THE LIFESCAN PRODUCT HAS BEEN RETURNED TO LIFESCAN. EVALUATION HAS NOT YET BEEN COMPLETED. AFTER THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING UNIT POWERS OFF DURING USE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED 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
    124942 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3376973

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR