BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO METER

    MDR report key: 3954257 · Received July 24, 2014

    Report

    Report Number
    2939301-2014-18314
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Report Date
    July 12, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K093745
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) AUSTRALIA ALLEGING THE ONETOUCH VERIO METER READ INACCURATELY ERRATIC. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF ¿7.0, 11.2, 6.5, 8.1, 6.3, AND 7.0MMOL/L¿ WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED RESULTS DID NOT MEET LIFESCAN¿S ACCURACY/PRECISION CRITERIA AND THE ALLEGED INACCURACY 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
    433457 OT VERIO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3620157

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR