BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CALCIUM_2 ASSAY

    MDR report key: 1295857 · Received January 23, 2009

    Report

    Report Number
    2432235-2009-00013
    Event Type
    Other
    Date Received
    January 23, 2009
    Date of Event
    January 7, 2009
    Report Date
    January 7, 2009
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K974607
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAD CHANGED THE REAGENT WEDGE DURING NORMAL TROUBLESHOOTING PROCEDURES, THE SYSTEM WAS CALIBRATED AND QC WAS RUN WITH ALL RESULTS BEING NORMAL. A SIEMENS HEALTHCARE DIAGNOSTIC INC. FIELD SERVICE REPRESENTATIVE (FSE) WAS DISPATCHED TO THE ACCOUNT. HE CHECKED THE SYSTEM OUT, AND RAN SEVERAL QC TESTS. ALL CAME OUT NORMAL. THE DEVICE IS OPERATING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED INTERMITTENTLY LOW ADVIA 1650 CALCIUM CA_2 PT RESULTS TO THE PHYSICIAN. THE QC RUN DATA WAS ACCEPTABLE. CUSTOMER REPEATED THE SAMPLE ON AN ALTERNATE ANALYZER AND THE CALCIUM RESULTS WERE HIGHER. PT 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 CALCIUM_2 ASSAY CALCIUM ARSENAZO III METHOD JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1