BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO METER

    MDR report key: 2883601 · Received December 21, 2012

    Report

    Report Number
    3008382007-2012-08795
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Report Date
    December 14, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K093745
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER PASSED TESTING WITH NO FAULTS FOUND. THE METER MET SPECIFICATION AND WAS FOUND TO FUNCTION PROPERLY. 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

    PRODUCT WAS REPLACED AND REQUESTED BACK. SERIAL# AND LOT # OF THE TEST STRIPS WAS NOT PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING INACCURATE CONTROL RESULTS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED SINCE THE TEST STRIPS FELL OUT OF RANGE. NO EVIDENCE OF A SERIOUS INJURY OR THAT THE PATIENT EXHIBITED ANY SYMPTOMS DUE TO THE ALLEGED ISSUE. 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 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1