BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 4212227 · Received October 30, 2014

    Report

    Report Number
    2939301-2014-29075
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 - 1/19/2015 DEVICE EVALUATION:THE LAY USER/PATIENTS TEST STRIPS HAVE BEEN RETURNED ON 12/17/2014 AND FURTHER EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 1/12/2015 WITH THE FOLLOWING FINDINGS:THE TEST STRIPS INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE TEST STRIPS WERE EVALUATED AND FOUND TO BE MISCLASSIFIED BY THE METER. THE METER REPORTED ¿CONTROL SOLUTION¿ WHEN BLOOD HAS BEEN APPLIED TO A STRIP. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING BLOOD READING AS CONTROL. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED 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
    696134 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3623403

    Patients

    Seq Age Sex Outcome Treatment
    1