BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 4260903 · Received November 19, 2014

    Report

    Report Number
    2939301-2014-31232
    Event Type
    Malfunction
    Date Received
    November 19, 2014
    Report Date
    October 29, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (02/04/2015). THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED ON 1/12/2015 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 1/21/2015 WITH THE FOLLOWING FINDINGS:THE TEST STRIPS INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE TEST STRIPS WERE FOUND TO HAVE RESULTS BELOW RANGE WHEN TESTED WITH CONTROL SOLUTION. 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 THE SUBJECT METER READ INACCURATELY LOW COMPARED TO ANOTHER DEVICE. THE REPORTER CLAIMED TO HAVE OBTAINED BLOOD GLUCOSE READINGS OF "130 MG/DL" WITH THE SUBJECT METER AND "186 MG/DL" ON ANOTHER DEVICE, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. 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
    750918 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3677572

    Patients

    Seq Age Sex Outcome Treatment
    1