BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3101038 · Received May 9, 2013

    Report

    Report Number
    3008382007-2013-10739
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    July 13, 2012
    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
    US
    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)(6) 2012, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING THAT THE SUBJECT METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THE RESULTS OBTAINED ON THE SUBJECT METER AND ON THE OTHER METER ARE UNKNOWN, BUT THE USER DID INDICATE THAT THE OTHER METER READS ABOUT "30-50 POINTS BELOW" THE SUBJECT METER, AND THAT "ONE TEST THAT WAS IN THE 300'S WAS OFF BY 78". THE LENGTH OF TIME BETWEEN THE TESTS IS ALSO UNKNOWN. THIS COMPLAINT IS BEING REPORTED BECAUSE WE ARE UNABLE TO DETERMINE IF THE REPORTED RESULTS MEET LIFESCAN'S ACCURACY CRITERIA, AND THE ALLEGED INACCURACY 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
    204494 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1