BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 1000 TURBO INTACT PTH

    MDR report key: 1313235 · Received February 13, 2009

    Report

    Report Number
    2017183-2008-00071
    Event Type
    Other
    Date Received
    February 13, 2009
    Date of Event
    November 18, 2008
    Report Date
    November 20, 2008
    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
    NY, 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 EVALUATION 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 PATIENT SAMPLE DURING SURGERY. INITIAL RESULT PRIOR TO THE PROCEDURE WAS IN NORMAL RANGE AND CONFIRMED WITH REPEATED RESULT. THE SURGERY PROCEDURE WAS CEASED WHEN THE LOW DISCORDANT RESULT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPEATED WITH HIGH RESULTS. POST-SURGERY SAMPLE ASSAY RESULTS WERE ALSO GENERATED AS HIGH RESULTS. THE PATIENT HAD A SECOND SURGERY DUE TO THE LOW DISCORDANT RESULT. PATIENT TREATMENT WAS ALTERED BASED ON THE LOWER ASSAY RESULT. THE REPORT INDICATED THAT PATIENT SURGERY WAS INTERVENED, DUE TO THE DISCORDANT INTACT PTH ASSAY RESULTS.

    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 151

    Patients

    Seq Age Sex Outcome Treatment
    1 Other