BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO TEST STRIPS

    MDR report key: 2925997 · Received January 23, 2013

    Report

    Report Number
    3008382007-2013-01336
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Report Date
    December 28, 2012
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE TEST STRIP PASSED TESTING WITH NO FAULTS FOUND.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

    THIS CORRECTION IS BEING SENT TO ADD ADDITIONAL INFORMATION THAT WAS MISSING FROM A PREVIOUS SUPPLEMENTAL REPORT.FOLLOW-UP # 3 (6/25/2013)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 5/24/2013 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING. THE COMPLAINT RELATING TO THIS DEVICE COULD NOT BE REPRODUCED. 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)(4) 2012, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING INACCURATE RESULTS COMPARED TO THE SAME METER WITH RESULTS OF "18.3, 12.2 AND 9.6MMOL/L." THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED RESULTS DID NOT MEET LIFESCAN'S ACCURACY/PRECISION 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
    32275 OT VERIO TEST STRIPS GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3386295

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR