BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO FLEX METER

    MDR report key: 6057226 · Received October 26, 2016

    Report

    Report Number
    3008382007-2016-55239
    Event Type
    Malfunction
    Date Received
    October 26, 2016
    Report Date
    October 17, 2016
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K150214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 THAT THE SUBJECT METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE (FREESTYLE). THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF ¿181, 174 AND 200 MG/DL¿ WITH THE SUBJECT METER AND ¿165, 155 AND 122 MG/DL¿ ON THE OTHER DEVICE, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN¿S CRITERIA FOR ACCURACY. 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
    710244 OT VERIO FLEX METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 4053058

    Patients

    Seq Age Sex Outcome Treatment
    1