BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3924551 · Received July 10, 2014

    Report

    Report Number
    2939301-2014-16885
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Report Date
    July 4, 2014
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (09/08/2014) DEVICE EVALUATION:THE LAY USER/PATIENT¿S METER HAS BEEN RETURNED ON 08/08/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 09/02/2014 WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE METER WAS TESTED AND THE PRIMARY COMPLAINT WAS NOT 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

    DEVICE EVALUATION: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(6) 2014 FOLLOWING FINDINGS: THE TEST STRIP HAS PASSED TESTING FOR THE ALLEGED INACCURATE ISSUE. THE REPORTED ISSUE COULD NOT BE REPRODUCED. UNRELATED TO THE REPORTED ISSUE, AN ERROR 4 ISSUE WAS FOUND DURING PA TESTING FOR THE SUBJECT TEST STRIPS. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405289 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3565868

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR