BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 4123881 · Received September 27, 2014

    Report

    Report Number
    2939301-2014-25646
    Event Type
    Malfunction
    Date Received
    September 27, 2014
    Report Date
    September 19, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (12/03/2014). THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED ON 10/28/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 11/21/2014 WITH THE FOLLOWING FINDINGS:THE TEST STRIPS INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE RETURNED TEST STRIPS, WHEN TESTED WITH CONTROL SOLUTION, DO NOT FILL. A SECONDARY ISSUE WAS NOTED WHEN THE TEST STRIPS WERE FOUND TO HAVE RESULTS BELOW RANGE WHEN TESTED WITH CONTROL SOLUTION. TERTIARY AND QUATERNARY ISSUES WERE NOTED WHERE ERROR 4 AND ERROR 5 WERE OBSERVED DURING CONTROL SOLUTION TESTS. QUINARY, THE TEST STRIPS WERE FOUND TO BE CONTAMINATED WITH AN UNKNOWN SUBSTANCE. 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 SAMPLE NOT DRAWN IN. 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
    603888 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3668487

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR