BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3260041 · Received August 1, 2013

    Report

    Report Number
    3008382007-2013-21769
    Event Type
    Malfunction
    Date Received
    August 1, 2013
    Report Date
    July 11, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Removal / Correction Number
    2013-IE-017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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) 2013, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING INACCURATE RESULT OF "700MG/DL" AS COMPARED TO "150MG/DL". PER THE ONETOUCH VERIO IQ OWNER'S MANUAL THE METER'S REPORTED RESULT RANGE IS "20-600MG/DL." IF THE BLOOD GLUCOSE SAMPLE EXCEEDS 600MG/DL THEN THE METER WOULD DISPLAY "EXTREME HIGH GLUCOSE" ON THE SCREEN AND NOT REPORT A VALUE. THIS COMPLAINT IS BEING REPORTED DUE TO THE USUAL ISSUE OF THE METER ALLEGEDLY REPORTING A RESULT BEYOND THE REPORTABLE RANGE IN ADDITION TO NOT MEETING LFS' CRITERIA FOR ACCURACY WHEN COMPARED AGAINST ANOTHER METER. 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
    360903 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR