BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2000

    MDR report key: 1874231 · Received October 12, 2010

    Report

    Report Number
    2247117-2010-00046
    Event Type
    Other
    Date Received
    October 12, 2010
    Date of Event
    September 27, 2010
    Report Date
    September 29, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJQ
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. ANALYSIS OF THE INSTRUMENT AND THE INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT IPTH RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT LOW IMMULITE 2000 IPTH (PTH) RESULT WAS OBTAINED FOR ONE (1) PATIENT SAMPLE. THE LABORATORY QUESTIONED THE RESULT SINCE IT WAS HIGH AND THEY REPEATED THE SAME SAMPLE RECEIVING A DISCORDANTLY LOW RESULT. THE FOLLOWING DAY THE SAMPLE WAS AGAIN RE-TESTED AND THE RESULTS WERE REPORTED TO THE PHYSICIAN. THE DISCORDANT LOW IPTH RESULT WAS NOT REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT IPTH 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