BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 4133936 · Received October 2, 2014

    Report

    Report Number
    2939301-2014-26050
    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
    MA, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    THE PATIENT¿S TEST STRIPS AND CONTROL SOLUTION HAVE BEEN RETURNED ON (B)(6) 2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 1/19/2015 AND 1/7/2015, RESPECTIVELY, 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 CONTAIN MORE MOISTURE THAN EXPECTED FROM NORMAL USE (AS PER PRODUCT LABELLING) AND FAILED TGA TESTING. THE CONTROL SOLUTION WAS ALSO TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING INACCURATELY HIGH CONTROL SOLUTION RESULTS. THE REPORTER OBTAINED A CONTROL SOLUTION READING OF "139MG/DL" ON THE SUBJECT METER (ONETOUCH VERIO IQ). THIS FALLS OUT WITH THE CONTROL SOLUTION RANGE OF "102-138MG/DL" FOR THIS STRIP LOT. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE REPORTED RESULTS DID NOT MEET LIFESCAN¿S ACCURACY CRITERIA AND 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
    614416 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3627996

    Patients

    Seq Age Sex Outcome Treatment
    1