BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM ULTRASENSITIVE HTSH II

    MDR report key: 3781578 · Received April 30, 2014

    Report

    Report Number
    3005094123-2014-00010
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 10, 2014
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    JLW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. AN EVALUATION IS IN PROCESS.

    Additional Manufacturer Narrative · 1

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE IN QUESTION WAS CHANGED FROM THE AXSYM ULTRASENSITIVE HTSH II ASSAY, LIST NUMBER 01L73-20, TO THE ABBOTT AXSYM ANALYZER, LIST NUMBER 07A83. THIS CHANGES THE MANUFACTURING LOCATION. MDR 1628664-2014-00119 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER. AN EVALUATION IS IN-PROCESS.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A FALSELY DECREASED AXSYM ULTRASENSITIVE HTSH II RESULT. THE CUSTOMER PROVIDED THE FOLLOWING RESULTS (UIU/ML): INITIAL: >100, RETEST 0.6. THE SPECIMEN WAS TESTED USING ANOTHER METHOD AT A DIFFERENT LABORATORY GENERATING A RESULT OF APPROXIMATELY 80. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260070 AXSYM ULTRASENSITIVE HTSH II HTSH JLW A.I.D.D LONGFORD 31046UI00

    Patients

    Seq Age Sex Outcome Treatment
    1 ABBOTT AXSYM ANALYZER| LN 07A83-01, SN (B)(4)