BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000

    MDR report key: 2342432 · Received November 18, 2011

    Report

    Report Number
    2247117-2011-00072
    Event Type
    Malfunction
    Date Received
    November 18, 2011
    Date of Event
    October 22, 2011
    Report Date
    October 26, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    JWL
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GPS INSTRUMENT SUPPORT SPECIALIST REVIEWED THE INSTRUMENT FILES AND FOUND NO INDICATION OF AN INSTRUMENT ISSUE RELATED TO THIS FALSE (B)(6) SYPHILIS RESULT. IT WAS DETERMINED THAT THE CAUSE OF THE FALSE (B)(6) SYPHILIS RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSE (B)(6) SYPHILIS RESULT ON ONE PATIENT SAMPLE WAS GENERATED ON THE IMMULITE 2000. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME PATIENT SAMPLE WAS RE-TESTED (REPEAT) ON THE SAME INSTRUMENT AND A SYPHILIS RESULT WAS GENERATED THAT WAS (B)(6). THIS RESULT WAS NOT REPORTED. THERE IS NO KNOWN REPORT OF ADVERSE HEALTH CONSEQUENCES OR PATIENT INTERVENTION DUE TO THE FALSE (B)(6) SYPHILIS RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 IMMULITE 2000 JWL SIEMENS HEALTHCARE DIAGNOSTICS, INC. IMMULITE 2000 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1