BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIOVUE METER

    MDR report key: 4958881 · Received August 1, 2015

    Report

    Report Number
    2939301-2015-32278
    Event Type
    Malfunction
    Date Received
    August 1, 2015
    Report Date
    July 15, 2015
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. 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

    FOLLOW UP # 2: ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT WAS NOT AVAILABLE AT THE TIME OF THE INITIAL REPORT. THE REPORTER ALSO ALLEGED THAT THE SUBJECT METER READ INACCURATELY HIGH COMPARED TO ANOTHER METER (ONETOUCH ULTRAVUE). EXACT METER READINGS WERE NOT PROVIDED. THE TESTS WERE PERFORMED WITHIN AN UNKNOWN TIME OF EACH OTHER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE RESULTS MAY NOT HAVE MET LIFESCAN¿S ACCURACY CRITERIA AND THE ALLEGED INACCURACY ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    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 PRODUCT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE 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) 2015, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING THAT THE SUBJECT METER READ INACCURATELY HIGH COMPARED TO A LABORATORY DEVICE. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF ¿177, 164, 144, 132, 201 AND 167 MG/DL¿ WITH THE SUBJECT METER AND ¿147, 129, 125, 83, 138 AND 83 MG/DL¿ ON THE LABORATORY DEVICE. THE TESTS WERE PERFORMED WITHIN 10 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN¿S CRITERIA FOR ACCURACY. 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
    502762 OT VERIOVUE METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3746720

    Patients

    Seq Age Sex Outcome Treatment
    1