BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO2 METER

    MDR report key: 5220380 · Received November 12, 2015

    Report

    Report Number
    2939301-2015-48392
    Event Type
    Malfunction
    Date Received
    November 12, 2015
    Report Date
    November 2, 2015
    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
    PA, 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) 2015, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING AN INACCURATE HIGH CONTROL SOLUTION RESULTS. THE REPORTER CLAIMED OBTAINING A CONTROL SOLUTION RESULT OF ¿157, 192, 163 AND 167 MG/DL¿ WHICH FELL ABOVE THE SPECIFIED CONTROL SOLUTION RANGE PRINTED ON THE TEST STRIP VIAL. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED INACCURACY CONTROL 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
    749829 OT VERIO2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3885658

    Patients

    Seq Age Sex Outcome Treatment
    1