BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 XPI

    MDR report key: 2199955 · Received August 10, 2011

    Report

    Report Number
    2247117-2011-00050
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 24, 2011
    Report Date
    July 25, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JZO
    PMA / PMN Number
    P010050/S012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS TECHNICAL SERVICE ENGINEER (TSE) EVALUATED THE IMMULITE 2000 XPI INSTRUMENT DATA. ANALYSIS OF THE INSTRUMENT DATA INDICATES THAT THE CAUSE OF THE DISCORDANT ATG RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT LOW IMMULITE 2000 XPI ATG RESULTS WERE GENERATED ON ONE PATIENT SAMPLE. THE PATIENT HAD BEEN PREVIOUSLY FOLLOWED BY ANOTHER LABORATORY FOR A YEAR AND HAD TESTED POSITIVE. DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THERE WAS NO KNOWN REPORT OF TREATMENT GIVEN OR WITHHELD BASED ON THE DISCORDANT ATG RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 XPI IMMUNO-ASSAY JZO SIEMENS HEALTHCARE DIAGNOSTICS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1