BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2000 AFP

    MDR report key: 1659077 · Received April 12, 2010

    Report

    Report Number
    2017183-2010-00016
    Event Type
    Other
    Date Received
    April 12, 2010
    Report Date
    March 15, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    GKZ
    PMA / PMN Number
    K983263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE SYSTEM DATA INDICATE THAT THERE ARE NO KNOWN CAUSES WHICH MAY HAVE CONTRIBUTED TO THE DISCORDANT LOW IMMULITE 2000 AFP TEST RESULTS. THERE IS NO EVIDENCE OF ANY PT SAMPLE INTERFERENCE SUBSTANCE. THERE IS INSUFFICIENT DISCORDANT PATIENT SAMPLE AVAILABLE FOR F/U INVESTIGATION AND THE CUSTOMER HAS NOT PROVIDED ANY ADD'L INFORMATION. NO FURTHER EVAL OF THE DEVICE IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    A DISCORDANT LOW IMMULITE 2000 AFP ASSAY RESULT WAS OBTAINED UPON F/U AND REPEAT PT TESTING WHEN COMPARED TO TWO OTHER AFP ASSAY TEST METHODS. THERE WAS NO KNOWN REPORT OF PT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW DISCORDANT LOW IMMULITE AFP ASSAY RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 AFP AFP IMMUNOASSAY GKZ SIEMENS HEALTHCARE DIAGNOSTICS INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR