BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 2943925 · Received February 5, 2013

    Report

    Report Number
    3008382007-2013-02302
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Report Date
    January 23, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(4) 2013 THE USER IN (B)(6) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH VERIO PRO METER WAS GIVING INACCURATELY HIGH READINGS WITH THE CONTROL SOLUTION. THE PATIENT OBTAINED A CONTROL SOLUTION RESULT OF 146 MG/DL ON THE REPORTED METER WHICH WAS OUT OF RANGE HIGH. AS THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING THIS COMPLAINT IS BEING REPORTED. THERE WAS NO REPORT OF ANY PATIENT INJURY ASSOCIATED WITH THIS 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
    47941 OT VERIO PRO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1