BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3020455 · Received March 26, 2013

    Report

    Report Number
    3008382007-2013-06193
    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, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2 ¿ (07/24/2013).THE PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 3/11/2013 AND 7/18/2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.ADDITIONAL INFORMATION:THE PATIENT'S TEST STRIPS WERE RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 3/6/2013 AND 3/15/2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS:THE TEST STRIPS INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE RETURNED TEST STRIPS, WHEN TESTED WITH CONTROL SOLUTION, GAVE RESULTS ABOVE THE CONTROL SOLUTION RANGE.

    Additional Manufacturer Narrative · 1

    (3/22/2013)-DEVICE EVALUATION: THE LAY USER/PATIENTS PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT WERE FOUND HAVE RESULTS OUTSIDE THE ACCEPTABLE CONTROL RANGE. 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

    THE REPORTER CONTACTED LIFESCAN, ALLEGING INACCURATE RESULTS. THE PATIENT WAS NOT ABLE TO PROVIDE ANY NUMERIC VALUES FOR THE ALLEGED ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED INACCURACY 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
    124239 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3379534

    Patients

    Seq Age Sex Outcome Treatment
    1