BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2500 CALCITONIN

    MDR report key: 1613115 · Received February 9, 2010

    Report

    Report Number
    2017183-2010-00005
    Event Type
    Other
    Date Received
    February 9, 2010
    Date of Event
    December 24, 2009
    Report Date
    January 11, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JKR
    PMA / PMN Number
    K023304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE AND PERFORMED A FUNCTIONAL SYS EVAL. THE FSE WAS NOT ABLE TO DETERMINE THE CAUSE FOR THE DISCORDANT LOW CALCITONIN RESULT. THE INSTRUMENT IS PERFORMING WITHIN SPECS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT LOW IMMULITE CALCITONIN RESULT WAS OBTAINED ON A PREVIOUS FROZEN PT SAMPLE. THE INITIAL RESULT DID NOT CORRELATE WITH THE PT'S CLINICAL PICTURE AND WAS QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS SENT OUT TO ANOTHER LABORATORY PER THE CUSTOMER'S LABORATORY STANDARD OPERATING PROCEDURE AND THE CALCITONIN RESULT WAS HIGHER AND CORRELATED WITH THE CLINICAL PICTURE. THE SAMPLE WAS RETURNED ON THE IMMULITE 2500 AND THE REPEAT RESULT CORRELATED WITH THE CLINICAL PICTURE. THERE WAS NO REPORT OF PT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT LOW CALCITONIN ASSAY RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2500 CALCITONIN CALCITONIN IMMUNOASSAY JKR SIEMENS HEALTHCARE DIAGNOSTICS INC NA 123

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR