BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 1000 TURBO INTACT PTH

    MDR report key: 1423276 · Received March 23, 2009

    Report

    Report Number
    2017183-2009-00011
    Event Type
    Other
    Date Received
    March 23, 2009
    Date of Event
    February 5, 2009
    Report Date
    February 12, 2009
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CEW
    PMA / PMN Number
    K053533
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 INSTRUMENT AND DATA DID NOT INDICATE SYSTEM ERROR. THE CAUSE FOR THE DISCORDANT STAT INTACT PTH RESULTS IS UNKNOWN. NO FURTHER EVAL OF THE DEVICE IS REQUIRED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A DISCORDANT LOW POSITIVE IMMULITE 2500 STAT INTACT PTH WAS OBTAINED ON A PT SAMPLE DURING SURGERY. INITIAL RESULT PRIOR TO THE PROCEDURE WAS IN NORMAL RANGE AND CONFIRMED WITH REPEATED RESULT. PHYSICIAN QUESTIONED THE RESULTS. THE SAME SAMPLE WAS REPEATED WITH HIGH RESULTS. PT'S TREATMENT WAS NOT ALTERED AND THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT INTACT PTH ASSAY RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 1000 TURBO INTACT PTH INTACT PTH IMMUNOASSAY CEW SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 152

    Patients

    Seq Age Sex Outcome Treatment
    1 Other