BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2500

    MDR report key: 1624778 · Received March 2, 2010

    Report

    Report Number
    2247117-2010-00007
    Event Type
    Other
    Date Received
    March 2, 2010
    Date of Event
    January 25, 2010
    Report Date
    February 5, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJQ
    PMA / PMN Number
    K905215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 EVALUATION. AFTER EVALUATION OF THE INSTRUMENT, THE FSE DETERMINED THAT THE CAUSE OF THE DISCREPANT ACT RESULTS WAS A LOOSE SAMPLE PROBE THAT WAS LEAKING. THE FSE REPAIRED THE SYSTEM. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT LOW ACT RESULTS WERE OBTAINED ON 3 PATIENT SAMPLES. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE LABORATORY QUESTIONED THE RESULTS DUE TO THE PATIENT'S CLINICAL PICTURES, AND THE SAMPLES WERE REPEATED. THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ACT RESULTS.

    Additional Manufacturer Narrative · 2

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR INSTRUMENT EVALUATION. AFTER EVALUATION OF THE INSTRUMENT, THE FSE DETERMINED THAT THE CAUSE OF THE DISCREPANT ACT RESULTS WAS A LOOSE SAMPLE PROBE THAT WAS LEAKING. THE FSE REPAIRED THE SYSTEM. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 2

    DISCORDANT LOW ACT RESULTS WERE OBTAINED ON 3 PATIENT SAMPLES. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE LABORATORY QUESTIONED THE RESULTS DUE TO THE PATIENTS' CLINICAL PICTURES, AND THE SAMPLES WER REPEATED. THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ACT RESULTS.

    Additional Manufacturer Narrative · 3

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR INSTRUMENT EVALUATION. AFTER EVALUATION OF THE INSTRUMENT, THE FSE DETERMINED THAT THE CAUSE OF THE DISCREPANT ACT RESULTS WAS A LOOSE SAMPLE PROBE THAT WAS LEAKING. THE FSE REPAIRED THE SYSTEM. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 3

    DISCORDANT LOW ACT RESULTS WERE OBTAINED ON 3 PATIENT SAMPLES. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE LABORATORY QUESTIONED THE RESULTS DUE TO THE PATIENTS' CLINICAL PICTURES, AND THE SAMPLES WER REPEATED. THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ACT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2500 IMMUNO-ASSAY JJQ SIEMENS HEALTHCARE DIAGNOSTICS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1
    2
    3