BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 3982509 · Received August 6, 2014

    Report

    Report Number
    2939301-2014-19778
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Report Date
    July 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

    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 # 1 ¿ (09/24/2014), DEVICE EVALUATION: THE LAY USER/PATIENT¿S PRODUCTS HAVE BEEN RETURNED ON 08/25/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 09/22/2014 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. THE TEST STRIPS WERE TESTED AND THE PRIMARY 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED LIFESCAN USA ALLEGING THAT THE SUBJECT METER (ONETOUCH ULTRALINK) READ INACCURATELY LOW COMPARED TO ANOTHER DEVICE (ONETOUCH ULTRAMINI). THE REPORTER CLAIMED OBTAINING A BLOOD GLUCOSE READING OF "54MG/DL" WITH THE SUBJECT METER AND "95MG/DL" ON THE OTHER DEVICE, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN¿S CRITERIA FOR ACCURACY. 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
    461019 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3547249

    Patients

    Seq Age Sex Outcome Treatment
    1