BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2000

    MDR report key: 1613142 · Received February 11, 2010

    Report

    Report Number
    2247117-2010-00004
    Event Type
    Other
    Date Received
    February 11, 2010
    Date of Event
    January 13, 2010
    Report Date
    January 13, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    DGC
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR INSTRUMENT EVAL. ANALYSIS OF THE INSTRUMENT AND THE INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT HCG RESULTS CANNOT BE DETERMINED. AFTER EVAL OF THE INSTRUMENT, THE FSE REPLACED BOTH PROBE ASSEMBLIES, AND DECONTAMINATED THE FLUIDIC AND SUBSTRATE SYSTEMS. THE INSTRUMENT IS PERFORMING WITHIN SPECS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT LOW HCG RESULTS WERE OBTAINED ON 3 PATIENT SAMPLES. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE SAMPLES WERE REPEATED ON THE LAB'S SECOND IMMULITE 2000 SYSTEM (B)(4). THE REPEAT RESULTS FROM (B)(4) WERE REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WERE NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HCG RESULTS.

    Additional Manufacturer Narrative · 2

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR INSTRUMENT EVAL. ANALYSIS OF THE INSTRUMENT AND THE INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT HCG RESULTS CANNOT BE DETERMINED. AFTER EVAL OF THE INSTRUMENT, THE FSE REPLACED BOTH PROBE ASSEMBLIES, AND DECONTAMINATED THE FLUIDIC AND SUBSTRATE SYSTEMS. THE INSTRUMENT IS PERFORMING WITHIN SPECS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 2

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR INSTRUMENT EVAL. ANALYSIS OF THE INSTRUMENT AND THE INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT HCG RESULTS CANNOT BE DETERMINED. AFTER EVAL OF THE INSTRUMENT, THE FSE REPLACED BOTH PROBE ASSEMBLIES, AND DECONTAMINATED THE FLUIDIC AND SUBSTRATE SYSTEMS. THE INSTRUMENT IS PERFORMING WITHIN SPECS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 2

    DISCORDANT LOW HCG RESULTS WERE OBTAINED ON 3 PATIENT SAMPLES. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE SAMPLES WERE REPEATED ON THE LAB'S SECOND IMMULITE 2000 SYSTEM (B)(4). THE REPEAT RESULTS FROM (B)(4) WERE REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WERE NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HCG RESULTS.

    Description of Event or Problem · 2

    DISCORDANT LOW HCG RESULTS WERE OBTAINED ON 3 PATIENT SAMPLES. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE SAMPLES WERE REPEATED ON THE LAB'S SECOND IMMULITE 2000 SYSTEM (B)(4). THE REPEAT RESULTS FROM (B)(4) WERE REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WERE NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HCG RESULTS.

    Additional Manufacturer Narrative · 3

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR INSTRUMENT EVAL. ANALYSIS OF THE INSTRUMENT AND THE INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT HCG RESULTS CANNOT BE DETERMINED. AFTER EVAL OF THE INSTRUMENT, THE FSE REPLACED BOTH PROBE ASSEMBLIES, AND DECONTAMINATED THE FLUIDIC AND SUBSTRATE SYSTEMS. THE INSTRUMENT IS PERFORMING WITHIN SPECS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 3

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR INSTRUMENT EVAL. ANALYSIS OF THE INSTRUMENT AND THE INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT HCG RESULTS CANNOT BE DETERMINED. AFTER EVAL OF THE INSTRUMENT, THE FSE REPLACED BOTH PROBE ASSEMBLIES, AND DECONTAMINATED THE FLUIDIC AND SUBSTRATE SYSTEMS. THE INSTRUMENT IS PERFORMING WITHIN SPECS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 3

    DISCORDANT LOW HCG RESULTS WERE OBTAINED ON 3 PATIENT SAMPLES. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE SAMPLES WERE REPEATED ON THE LAB'S SECOND IMMULITE 2000 SYSTEM (B)(4). THE REPEAT RESULTS FROM (B)(4) WERE REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WERE NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HCG RESULTS.

    Description of Event or Problem · 3

    DISCORDANT LOW HCG RESULTS WERE OBTAINED ON 3 PATIENT SAMPLES. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE SAMPLES WERE REPEATED ON THE LAB'S SECOND IMMULITE 2000 SYSTEM (B)(4). THE REPEAT RESULTS FROM (B)(4) WERE REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WERE NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HCG RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1
    2
    3