BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 3000897 · Received March 13, 2013

    Report

    Report Number
    3008382007-2013-04708
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Report Date
    February 12, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ((B)(4) 2013)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS (PA) ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE METER WAS EVALUATED AND NO ERROR MESSAGE WAS OBSERVED; HOWEVER, A SECONDARY ISSUE WAS NOTED WHERE THE METER WAS FOUND TO HAVE A DEFECTIVE PROCESSOR. 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 SUBJECT METER HAS BEEN RETURNED TO LIFESCAN FOR EVALUATION. THE EVALUATION OF THE PRODUCT HAS NOT BEEN COMPLETED; THEREFORE, NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILLED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, 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
    105305 OT VERIO PRO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR