BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 4134015 · Received October 2, 2014

    Report

    Report Number
    2939301-2014-26125
    Event Type
    Malfunction
    Date Received
    October 2, 2014
    Report Date
    September 24, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (02/17/2015). THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED ON 10/29/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 1/22/2015 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 TEST STRIP VIAL AND THE DESICCANT TO CHECK THE STRUCTURAL INTEGRITY AND FOR POSSIBLE MOISTURE ISSUE. THE STRUCTURAL INTEGRITY OF THE TEST STRIP VIAL WAS FOUND TO BE INTACT DURING A GROSS LEAK TEST. THE DESICCANT WITHIN THE SUBJECT VIAL WAS FOUND TO BE INTACT, THUS NOT THE ROOT CAUSE FOR THE CONTROL SOLUTION FAILING WHICH WAS SEEN, 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 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) 2014, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING INACCURATELY HIGH RESULTS WITH THEIR ONETOUCH VERIO IQ METER. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS BETWEEN "270-280MG/DL" WITH THE SUBJECT METER. THESE READINGS WERE COMPARED TO THE FOLLOWING READINGS: "163MG/DL" (FREESTYLE METER), "176MG/DL" (ONETOUCH ULTRAMINI METER), "172MG/DL" (ONETOUCH ULTRAMINI METER) AND "169MG/DL" (FREESTYLE METER).THESE RESULTS WERE OBTAINED FROM TESTS PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN¿S CRITERIA FOR ACCURACY. THE 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
    616699 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3612060

    Patients

    Seq Age Sex Outcome Treatment
    1