BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 4571590 · Received March 5, 2015

    Report

    Report Number
    2939301-2015-08672
    Event Type
    Malfunction
    Date Received
    March 5, 2015
    Report Date
    February 9, 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
    IL, 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 INACCURATE HIGH RESULT(S) COMPARED TO ANOTHER METER. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF 150, 110 AND 112 MG/DL WITH THE SUBJECT METER AND 110-118 MG/DL WITH ANOTHER METER (OT ULTRA MINI), WITHIN 30 MINUTES. THIS COMPLAINT IS BEING REPORTED BECAUSE IT DOES NOT MEET LIFESCAN¿S ACCURACY CRITERIA. 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
    154177 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3640200

    Patients

    Seq Age Sex Outcome Treatment
    1