BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H10

    MDR report key: 3065355 · Received April 18, 2013

    Report

    Report Number
    1219913-2013-00080
    Event Type
    Malfunction
    Date Received
    April 18, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    NBC
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    URGENT MEDICAL DEVICE CORRECTION ((B)(4)) WAS PROVIDED TO THE CUSTOMER. BRAND NAME COMMON DEVICE NAME CATALOG # PMA/510(K) CORECTION/REMOVAL # BNP ASSAY BNP IMMUNOASSAY 02816634 K031038 Z-0506-2013 02816138BR ASSAY BR IMMUNOASSAY 03896216 K982680 Z-0507-2013 02419937 09010686CA 19-9 ASSAY CA 19-9 IMMUNOASSAY 10491244 Z-0508-2013 10491379 03481938 04612750DHEA-SO4 ASSAY DHEA-SO4 IMMUNOASSAY 06489701 EXEMPT Z-0509-2013DIGITOXIN ASSAY DIGITOXIN IMMUNOASSAY 9046419 K970546 Z-0510-2013 08861968FOLATE ASSAY FOLATE IMMUNOASSAY 6891541 K010050 Z-0511-2013 06367974 09132781 00203473THEOPHYLLINE THEOPHYLLINE 2 08838753 K013272 Z-0512-20132 ASSAY IMMUNOASSAY 03009619ALL LOTS FOR EACH IMMUNOASSAY ARE INCLUDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY DID NOT RECEIVE AN ADVIA CENTAUR XP AMBIENT TEMPERATURE EFFECTS URGENT MEDICAL DEVICE CORRECTION ((B)(4)) THAT WAS DISTRIBUTED TO CUSTOMERS IN NOVEMBER 2012. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167606 SEE H10 SEE H10 NBC SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1