BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3062367 · Received April 16, 2013

    Report

    Report Number
    3008382007-2013-08040
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    March 19, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Removal / Correction Number
    2013-IE-017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (06/20/2013)-DEVICE EVALUATION: THE LAY USER/PATIENT¿S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 06/11/2013 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE EEPROM FAILURE. 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 PATIENT RETURNED THE SUBJECT TEST STRIPS. HOWEVER, THE EVALUATION OF THE PRODUCT IS NOT REQUIRED SINCE THE ALLEGED ISSUE REFERS TO METER ISSUE ONLY.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING ERROR 1. 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
    162602 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3394723

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR