BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 4212253 · Received October 30, 2014

    Report

    Report Number
    2939301-2014-29069
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Report Date
    October 22, 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
    NY, 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 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) 2014, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING THAT THE SUBJECT METER (ONETOUCH VERIOIQ) WAS READING INACCURATELY HIGH IN COMPARISON TO THE PATIENT'S FEELINGS OR NORMAL RESULTS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE DEVICE FAILED A CONTROL SOLUTION TEST DURING TROUBLESHOOTING. THERE WAS NO ALLEGATION OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695815 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3549311

    Patients

    Seq Age Sex Outcome Treatment
    1