BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 5349601 · Received January 7, 2016

    Report

    Report Number
    2939301-2016-00470
    Event Type
    Malfunction
    Date Received
    January 7, 2016
    Report Date
    December 16, 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
    HI, 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 THAT THE SUBJECT METER READ INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND/OR NORMAL READINGS. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF "170, 180, 270 AND 280MG/DL" WITH THE SUBJECT METER. THIS COMPARISON DOES NOT MEET THE CRITERIA NECESSARY FOR LIFESCAN TO DETERMINE THE POSSIBILITY OF AN INACCURACY, HOWEVER THIS COMPLAINT IS BEING REPORTED BECAUSE THE CONTROL SOLUTION TEST PERFORMED FELL OUT WITH THE CONTROL SOLUTION RANGE FOR THIS TEST STRIP LOT. 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
    10108 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3889079

    Patients

    Seq Age Sex Outcome Treatment
    1