BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 3713457 · Received March 31, 2014

    Report

    Report Number
    2939301-2014-07606
    Event Type
    Malfunction
    Date Received
    March 31, 2014
    Report Date
    March 22, 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
    FL, US
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    ON (B)(4) 2014, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING INACCURATE ERRATIC RESULTS. THE REPORTER OBTAINED BLOOD GLUCOSE VALUES OF 162, 263, 283, AND 277 MG/DL ON A LIFESCAN METER WITHIN 20 MINUTES OF EACH OTHER. THIS COMPLAINT IS BEING REPORTED FOR THE FOLLOWING REASON: BASED ON STATISTICAL METHODOLOGY, THE VARIATION BETWEEN THE TWO RESULTS EXCEEDS THE MAXIMUM ACCEPTABLE VALUE OF 20% VARIANCE BETWEEN READINGS TAKEN ON THE SAME METER WITHIN 20 MINUTES OF EACH OTHER. THE REPORTED RESULTS DID NOT MEET LIFESCAN'S ACCEPTABLE PRECISION 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. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189469 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3518622

    Patients

    Seq Age Sex Outcome Treatment
    1