BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2000

    MDR report key: 1744379 · Received June 29, 2010

    Report

    Report Number
    2247117-2010-00019
    Event Type
    Other
    Date Received
    June 29, 2010
    Date of Event
    May 6, 2010
    Report Date
    May 6, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJQ
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR INSTRUMENT EVAL. AFTER EVAL OF THE INSTRUMENT, THE FSE PRO-ACTIVELY REPLACED PARTS OF THE SAMPLE PROBE ASSEMBLY. HOWEVER, THE FSE CONCLUDED THAT THE CAUSE FOR THE DISCORDANT HCG, FE3 AND AFP RESULTS CAN NOT BE DETERMINED. THE INSTRUMENT IS PERFORMING WITHIN SPECS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT HCG, FE3 (UNCONJUGATED ESTRIOL) AND AFP RESULTS WERE OBTAINED ON THREE PT SAMPLES. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE LABORATORY QUESTIONED THE RESULTS AFTER NOTICING A DRIP ON THE SAMPLE PROBE, AND THE SAMPLES WERE REPEATED. THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN. PT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HCG, FE3 AND AFP RESULTS.

    Additional Manufacturer Narrative · 2

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR INSTRUMENT EVAL. AFTER EVAL OF THE INSTRUMENT, THE FSE PRO-ACTIVELY REPLACED PARTS OF THE SAMPLE PROBE ASSEMBLY. HOWEVER, THE FSE CONCLUDED THAT THE CAUSE FOR THE DISCORDANT HCG, FE3 AND AFP RESULTS CAN NOT BE DETERMINED. THE INSTRUMENT IS PERFORMING WITHIN SPECS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 2

    DISCORDANT HCG, FE3 (UNCONJUGATED ESTRIOL) AND AFP RESULTS WERE OBTAINED ON THREE PT SAMPLES. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE LABORATORY QUESTIONED THE RESULTS AFTER NOTICING A DRIP ON THE SAMPLE PROBE, AND THE SAMPLES WERE REPEATED. THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN. PT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HCG, FE3 AND AFP RESULTS.

    Additional Manufacturer Narrative · 3

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR INSTRUMENT EVAL. AFTER EVAL OF THE INSTRUMENT, THE FSE PRO-ACTIVELY REPLACED PARTS OF THE SAMPLE PROBE ASSEMBLY. HOWEVER, THE FSE CONCLUDED THAT THE CAUSE FOR THE DISCORDANT HCG, FE3 AND AFP RESULTS CAN NOT BE DETERMINED. THE INSTRUMENT IS PERFORMING WITHIN SPECS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 3

    DISCORDANT HCG, FE3 (UNCONJUGATED ESTRIOL) AND AFP RESULTS WERE OBTAINED ON THREE PT SAMPLES. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE LABORATORY QUESTIONED THE RESULTS AFTER NOTICING A DRIP ON THE SAMPLE PROBE, AND THE SAMPLES WERE REPEATED. THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN. PT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HCG, FE3 AND AFP RESULTS.

    Additional Manufacturer Narrative · 4

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR INSTRUMENT EVAL. AFTER EVAL OF THE INSTRUMENT, THE FSE PRO-ACTIVELY REPLACED PARTS OF THE SAMPLE PROBE ASSEMBLY. HOWEVER, THE FSE CONCLUDED THAT THE CAUSE FOR THE DISCORDANT HCG, FE3 AND AFP RESULTS CANNOT BE DETERMINED. THE INSTRUMENT IS PERFORMING WITHIN SPECS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 4

    DISCORDANT HCG, FE3 (UNCONJUGATED ESTRIOL) AND AFP RESULTS WERE OBTAINED ON THREE PT SAMPLES. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE LABORATORY QUESTIONED THE RESULTS AFTER NOTICING A DRIP ON THE SAMPLE PROBE, AND THE SAMPLES WERE REPEATED. THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN. PT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HCG, FE3 AND AFP RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 IMMUNO-ASSAY JJQ SIEMENS HEALTHCARE DIAGNOSTICS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1
    2
    3
    4