BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 4212221 · Received October 30, 2014

    Report

    Report Number
    2939301-2014-29066
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Report Date
    October 22, 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
    NY, 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 THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 - 1/20/2015, DEVICE EVALUATION: THE LAY USER/PATIENTS TEST STRIPS HAVE BEEN RETURNED ON (B)(4) 2014 AND FURTHER EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 1/20/2015 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. 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 NOT TO BE COMPROMISED DURING A GROSS LEAK TEST, THE VIAL PASSED PDT TESTING. THE DESICCANT WITHIN THE SUBJECT VIAL WAS FOUND TO BE TO BE SATURATED BY MOISTURE. THE VIAL FAILED 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

    TWO VIALS WERE RETURNED FOR TESTING ONLY ONE VIAL FAILED TGA TESTING. THE SECOND VIAL - THE DESICCANT WITHIN THE SUBJECT VIAL WAS FOUND TO BE NOT TO BE SATURATED BY MOISTURE AND PASSED TGA TESTING.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING THAT THE SUBJECT METER (ONE TOUCH VERIO IQ) READ INACCURATELY ERRATIC. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF "135, 167 AND 178MG/DL" WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS SATISFIES LIFESCAN¿S CRITERIA FOR PRECISION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE METER FAILED A CONTROL SOLUTION TEST DURING 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
    696132 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3683519

    Patients

    Seq Age Sex Outcome Treatment
    1