BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 4212241 · Received October 30, 2014

    Report

    Report Number
    2939301-2014-29044
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Report Date
    October 21, 2014
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (01/20/2015).THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED ON 12/17/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 1/8/2015 WITH THE FOLLOWING FINDINGS:THE TEST STRIPS INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE TEST STRIPS WERE FOUND TO HAVE RESULTS ABOVE RANGE WHEN TESTED WITH CONTROL SOLUTION. IN ADDITION, A SECONDARY ISSUE WAS NOTED WHERE ERROR 4 WAS OBSERVED DURING CONTROL SOLUTION TESTS. ADDITIONAL TESTS WERE PERFORMED ON THE DESICCANT TO CHECK FOR POSSIBLE MOISTURE ISSUE. THE DESICCANT WITHIN THE SUBJECT VIAL WAS FOUND TO CONTAIN LEVELS OF MOISTURE THAT REFLECT NORMAL USE AND PASSED TGA TESTING. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    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 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) 2014, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING THAT THE SUBJECT METER (ONETOUCH VERIO IQ) READ INACCURATELY ERRATIC. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF AROUND "120 MG/DL AND 200 MG/DL" WITH THE SUBJECT METER, BUT COULD NOT SPECIFY THE TIME DIFFERENCE BETWEEN TESTS. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN¿S CRITERIA FOR PRECISION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED 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
    695811 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3667099

    Patients

    Seq Age Sex Outcome Treatment
    1