BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2770997 · Received October 3, 2012

    Report

    Report Number
    2939301-2012-11379
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Report Date
    September 20, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    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 #2 (11/13/2012) DEVICE EVALUATION: THE SUBJECT TEST STRIPS FAILED TESTING, ON PERFORMANCE TESTING WITH LEVEL 2 CONTROL SOLUTION, THE TEST STRIPS WERE FOUND TO BE READING HIGH.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 (11/13/2012) DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED IN THIS COMPLAINT HAVE BEEN RETURNED TO LFS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 AND (B)(4) 2012 RESPECTIVELY WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED ALL TESTING WITH NO FAULTS FOUND, THE COMPLAINT WAS NOT CONFIRMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A SECOND FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE A PATIENT CONTACTED LIFESCAN ALLEGING THAT THE SUBJECT METER READ INACCURATELY HIGH COMPARED TO ANOTHER METER. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "196 MG/DL" WITH A LIFESCAN METER AND "132 MG/DL" ON ANOTHER METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3305848

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR