BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2500 STAT INTACT PTH

    MDR report key: 1282047 · Received December 16, 2008

    Report

    Report Number
    2017183-2008-00060
    Event Type
    Other
    Date Received
    December 16, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 7, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    CEW
    PMA / PMN Number
    K013566
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 STAT INTACT PTH RESULTS ARE UNK. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A LOW IMMULITE 2500 STAT INTACT PTH PT SAMPLE WAS REPORTED TO THE PHYSICIAN WHO ORDERED THE SAMPLE TO BE REPEATED. UPON REPEAT, THE INTACT PTH RESULT OBTAINED WAS HIGHER THAN THE INITIAL RESULT, WHICH WAS IN ALIGNMENT WITH THE PT'S CLINICAL PICTURE. PT TREATMENT WAS ADMINISTERED BASED ON THE HIGHER RESULT. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT STAT 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 STAT INTACT PTH RESULTS ARE UNK. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 2

    A LOW IMMULITE 2500 STAT INTACT PTH PT SAMPLE WAS REPORTED TOS THE PHYSICIAN WHO ORDERED THE SAMPLE TO BE REPEATED. UPON REPEAT, THE INTACT PTH RESULT OBTAINED WAS HIGHER THAN THE INITIAL RESULT, WHICH WAS IN ALIGNMENT WITH THE PT'S CLINICAL PICTURE. PT TREATMENT WAS ADMINISTERED BASED ON THE HIGHER RESULT. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT STAT INTACT PTH ASSAY RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2500 STAT INTACT PTH STAT INTACT PTH IMMUNOASSAY CEW SIEMENS HEALTHCARE DIAGNOSTICS, INC. NA 114

    Patients

    Seq Age Sex Outcome Treatment
    1
    2