BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3051964 · Received April 11, 2013

    Report

    Report Number
    3008382007-2013-07487
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Report Date
    March 14, 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 (6/19/2013) -DEVICE EVALUATION: THE METER AND USB CABLE INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 6/10/2013 AND 6/11/2013 RESPECTIVELY, WITH THE FOLLOWING FINDINGS: THE METER FAILED TESTING. A CONTACT ISSUE WAS FOUND WHERE A PIECE OF PAPER WAS AFFECTING THE SPC PIN CONTACT. IN ADDITION, THE USB CABLE WAS TESTED WITH NO FAULTS FOUND, AND THE COMPLAINT WAS UNABLE TO BE CONFIRMED. 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) 2013, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING DOES NOT TURN ON. 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
    156403 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3427465

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR