BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 3131876 · Received May 29, 2013

    Report

    Report Number
    3008382007-2013-13225
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 2, 2013
    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
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (07/05/2013)-DEVICE EVALUATION: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 06/27/2013 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. THE COMPLAINT WAS NOT 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

    THE TEST STRIPS ASSOCIATED WITH THIS COMPLAINT HAS BEEN RETURNED TO LIFESCAN; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2013. THE REPORTER CONTACTED LIFESCAN USA, ALLEGING ERROR UNKNOWN. THE REPORTER STATED, "DEAR NO-SERVICE DEPARTMENT--, NO-THANKS FOR WASTING MORE THAN AN 2-HOURS TODAY "TRYING" TO GET THROUGH TO YOU FOR SOME TROUBLESHOOTING! STARTING WITH (B)(6) TO MY (B)(4), WHO SUPPLIED MY INSULIN PUMP & METER, TO WASTING MY TIME CALLING (B)(6) WITH ABSOLUTELY NO RESPONSE. (B)(4) STARTED THE TROUBLESHOOTING BY OUR TESTING THAT THE METER & PUMP & FOUND THEY ARE INTERFACED. HOWEVER, LAST NIGHT I "TRIED" TESTING WITH MY METER 4 TIMES WITH ERROR MESSAGES "LOW BLOOD APPLIED, ETC." BUT THERE WAS MORE THAN ENOUGH BLOOD APPLIED. I PUT IN TWO NEW BATTERIES & TRIED TWO MORE TESTS. SO, SOMETHING'S DEFINITELY WRONG WITH YOUR METER. I HAVE ANOTHER BAYER METER & REELS ENOUGH FORM ABOUT 40 TESTS. I'M A DIABETIC OF (B)(6) YEARS & WANT TO STAY ON TRACK. BUT WITH YOUR KIND OF NO-SERVICE I'LL PROBABLY BE LOOKING FOR A DIFFERENT SUPPLIER!" 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
    235244 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3404982

    Patients

    Seq Age Sex Outcome Treatment
    1