BEUDAMED
    FDA Adverse Event Summary report: N

    IMMULITE 2000

    MDR report key: 2072221 · Received April 28, 2011

    Report

    Report Number
    2432235-2011-00057
    Date Received
    April 28, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 31, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K970227
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT PAPP-A RESULT IS UNKNOWN. PROACTIVELY, THE FSE REPLACED THE SAMPLE UPPER SEAL AND THE COIL LOWER SEAL DUE TO A SLIGHT LEAK AND RAN QC. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT IMMULITE 2000 PAPP-A RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN. THE PHYSICIAN QUESTIONED THE RESULT. UPON RETEST THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN. THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PAPP-A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 IMMUNOASSAY ANALYZER, PRODUCT CODE: JJE SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 2000 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1