BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO2 METER

    MDR report key: 5509734 · Received March 18, 2016

    Report

    Report Number
    2939301-2016-12806
    Event Type
    Malfunction
    Date Received
    March 18, 2016
    Report Date
    February 28, 2016
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K131363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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) 2016, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING INACCURATE ERRATIC RESULTS. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE RESULTS OF 400, 260 AND 190MG/DL ON THE SUBJECT METER WITHIN 20 MINUTES OF EACH OTHER. THEY ALSO REPORTED OBTAINING BLOOD GLUCOSE RESULTS OF 180, 156 AND 230MG/DL ON THE SUBJECT METER WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN'S CRITERIA FOR PRECISION. 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
    167590 OT VERIO2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3941226

    Patients

    Seq Age Sex Outcome Treatment
    1