BEUDAMED
    FDA Adverse Event Summary report: N

    OT VERIO IQ METER

    MDR report key: 5349983 · Received January 7, 2016

    Report

    Report Number
    2939301-2016-00840
    Date Received
    January 7, 2016
    Report Date
    December 14, 2015
    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
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    DEVICE EVALUATION: THE LAY USER/PATIENTS TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS PASSED TESTING. THE COMPLAINT WAS NOT CONFIRMED. IN ADDITION SECONDARY AND TERTIARY ISSUES WAS OBSERVED, THE TEST STRIPS WERE FOUND TO HAVE RESULTS BELOW THE RANGE WHEN TESTED WITH CONTROL SOLUTION AND TEST STRIPS WERE STUCK TOGETHER DUE TO NOT BEING CUT PROPERLY. ON (B)(6) 2015, THE REPORTER CONTACTED LIFESCAN (B)(4) ALLEGING THAT THE SUBJECT METER READ INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND/OR NORMAL READINGS. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF "250, 225 AND 255MG/DL" WITH THE SUBJECT METER. THIS COMPLAINT WAS INITIALLY RULED OUT BECAUSE THERE WAS NO INDICATION THAT THE PRODUCT MALFUNCTIONED DURING CUSTOMER SERVICE TROUBLESHOOTING AND THERE WAS ALSO NO ALLEGATION OF AN ADVERSE EVENT AS A RESULT OF THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10241 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3837103

    Patients

    Seq Age Sex Outcome Treatment
    1 115 YR