BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2500 INTACT PTH

    MDR report key: 1148643 · Received August 26, 2008

    Report

    Report Number
    2017183-2008-00036
    Event Type
    Other
    Date Received
    August 26, 2008
    Date of Event
    July 21, 2008
    Report Date
    July 22, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CEW
    PMA / PMN Number
    K013566
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT INTACT PTH RESULTS ARE UNKNOWN. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    LOW IMMULITE 2500 INTACT PTH ASSAY RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES. THE SAMPLES WERE RETESTED ON A DIFFERENT INSTRUMENT AND THE INTACT PTH RESULTS WERE POSITIVE ON BOTH SAMPLES. PATIENT'S TREATMENT WAS NOT ALTERED AND THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT INTACT PTH ASSAY RESULTS.

    Additional Manufacturer Narrative · 2

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT INTACT PTH RESULTS ARE UNKNOWN. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 2

    LOW IMMULITE 2500 INTACT PTH ASSAY RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES. THE SAMPLES WERE RETESTED ON A DIFFERENT INSTRUMENT AND THE INTACT PTH RESULTS WERE POSITIVE ON BOTH SAMPLES. PATIENT'S TREATMENT WAS NOT ALTERED AND THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT INTACT PTH ASSAY RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2500 INTACT PTH INTACT PTH IMMUNOASSAY CEW SIEMENS HEALTHCARE DIAGNOSTICS INC. N/A 126

    Patients

    Seq Age Sex Outcome Treatment
    1
    2