BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 4201381 · Received October 27, 2014

    Report

    Report Number
    2939301-2014-28676
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Report Date
    October 21, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING MULTIPLE INACCURATE HIGH COMPLAINTS AGAINST THE SUBJECT METER. THESE INCLUDE "168 MG/DL" COMPARED TO "138 MG/DL" ON A DOCTOR'S OFFICE METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. THE OTHER RESULTS WERE NOT SPECIFIED BUT WERE COMPARISONS WITH THE SUBJECT METER WHEN COMPARED TO AN UNKNOWN METER AND THE PATIENT'S WIFE'S METER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED RESULTS DID NOT 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 O AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683279 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3667095

    Patients

    Seq Age Sex Outcome Treatment
    1