BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 2884298 · Received December 22, 2012

    Report

    Report Number
    3008382007-2012-08855
    Event Type
    Malfunction
    Date Received
    December 22, 2012
    Report Date
    December 10, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP (6/6/2013)-DEVICE EVALUATION: LIFESCAN RECEIVED THE METER INVOLVED WITH THE COMPLAINT AND COMPLETED DEVICE EVALUATION ON 5/18/2013. THE ALLEGED ERROR MESSAGE WAS CONFIRMED IN THE METERS ERROR LOG: HOWEVER, THE ERROR MESSAGE WAS NOT REPRODUCIBLE DURING INVESTIGATIONS. THE CAUSE OF THE REPORTED ERROR MESSAGE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP (4/2/2013)-DEVICE EVALUATION: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE TEST STRIP HAS PASSED 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING ERROR 4. 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
    1 OT VERIO PRO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3246738

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR