BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CHEMISTRY 2400

    MDR report key: 2212214 · Received August 15, 2011

    Report

    Report Number
    2432235-2011-00114
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 3, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    JJE
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED TO THE CUSTOMER SITE TO EVALUATE THE INSTRUMENT AND INSTRUMENT DATA. AFTER ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA, THE FSE DETERMINED THAT THE CAUSE OF THE DISCORDANT CALCIUM RESULT WAS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT HIGH CALCIUM RESULT ON AN ADVIA 2400 CHEMISTRY SYSTEM WAS GENERATED ON ONE PATIENT SAMPLE. THE RESULT WAS REPORTED, HOWEVER THE LABORATORY REPEATED THE SAMPLE SINCE IT DID NOT MATCH PATIENT'S CLINICAL HISTORY. A CORRECTED REPORT WAS LATER SENT TO THE PHYSICIAN. CALCIUM SUPPLEMENTATION WAS DELAYED BASED ON THE INITIAL INCORRECT RESULT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CHEMISTRY 2400 CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CHEMISTRY 2400 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1