BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO2 METER

    MDR report key: 5352949 · Received January 8, 2016

    Report

    Report Number
    2939301-2016-00946
    Event Type
    Malfunction
    Date Received
    January 8, 2016
    Report Date
    January 4, 2016
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K093745
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PATIENT

    Narratives

    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.

    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

    FOLLOW UP #1: CORRECTION: (B)(6) 2016: THE METER WHICH WAS REPORTED IN THE INITIAL 3500A REPORT SHOULD HAVE BEEN THE ONETOUCH VERIO2 METER RATHER THAN THE ONETOUCH VERIO METER. THEREFORE, THE 510K NUMBER WHICH WAS POPULATED (K093745) SHOULD HAVE BEEN K131363.

    Description of Event or Problem · 1

    ON (B)(6) 2016, ON (B)(6) 2014, THE REPORTER CONTACTED LIFESCAN (B)(4) ALLEGING THAT THE SUBJECT METER READ INACCURATELY HIGH COMPARED TO A LAB DEVICE. THE REPORTER CLAIMED OBTAINING A BLOOD GLUCOSE READING OF "6.2MMOL/L" WITH THE SUBJECT METER AND "3.2MMOL/L" ON A LAB DEVICE, PERFORMED WITHIN 30 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
    14094 OT VERIO2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3774789

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR