BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CHEMISTRY CALCIUM_2 METHOD

    MDR report key: 1122365 · Received August 14, 2008

    Report

    Report Number
    2432235-2008-00096
    Event Type
    Other
    Date Received
    August 14, 2008
    Date of Event
    June 4, 2008
    Report Date
    August 4, 2008
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, INC.
    Product Code
    CJY
    PMA / PMN Number
    K974607
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE DIAGNOSTICS INC FIELD SERVICE REPRESENTATIVE (FSE) WAS DISPATCHED TO THE ACCOUNT. ANALYSIS OF THE INSTRUMENT INDICATED THAT THE RPP1 PROBE HEIGHT INTO RTT1 REQUIRED RE-ALIGNMENT, WHICH CAUSED THE ELEVATED CALCIUM RESULT. THE DEVICE IS OPERATING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ELEVATED ADVIA CHEMISTRY CALCIUM PATIENT RESULTS TO THE PHYSICIAN. THE QC RUN DATA WAS ACCEPTABLE. CUSTOMER REPEATED THE SAMPLE ON AN ALTERNATE ANALYZER AND THE CALCIUM RESULTS WERE LOWER. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CALCIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CHEMISTRY CALCIUM_2 METHOD CLINICAL CHEMISTRY CALCIUM METHOD CJY SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1