BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3811558 · Received May 15, 2014

    Report

    Report Number
    2939301-2014-11466
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    May 7, 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 ¿ (07/03/2014) DEVICE EVALUATION:THE LAY USER/PATIENT¿S PRODUCTS HAVE BEEN RETURNED ON 06/02/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 06/23/2014 WITH THE FOLLOWING FINDINGS:THE TEST STRIPS WERE EVALUATED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED; HOWEVER, THE TEST STRIPS WERE FOUND TO HAVE FAILED FOR AN ERROR 4 OBSERVATION DURING PERFORMANCE TESTING. 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) 2014, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING ERROR 2. 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
    291864 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3589958

    Patients

    Seq Age Sex Outcome Treatment
    1