BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA 2400

    MDR report key: 1624784 · Received March 2, 2010

    Report

    Report Number
    2432235-2010-00031
    Event Type
    Other
    Date Received
    March 2, 2010
    Date of Event
    February 3, 2010
    Report Date
    February 3, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSITCS INC.
    Product Code
    JJE
    PMA / PMN Number
    K990346
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. AFTER ANALYZING THE INSTRUMENT AND INSTRUMENT DATA, THE FSE CHECKED THE ALIGNMENT OF REAGENT PROBE 2 (RP2), ADJUSTED THE HEIGHT OF MIX 1 AND VERIFIED MIX 2. THE CUSTOMER CHANGED THE REAGENT WEDGES PRIOR TO PERFORMING REPEAT TESTING. BASED ON THE INFORMATION PROVIDED, NO CONCLUSION CAN BE DRAWN AS TO WHAT MAY HAVE CAUSED THE PROBLEM. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. THE SYSTEM WAS DETERMINED TO BE OPERATIONAL AND NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT CALCIUM (CA_2) RESULT ON AN ADVIA 2400 WAS OBTAINED FOR 1 PATIENT. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS RERUN ON THE SAME INSTRUMENT AND THE CORRECTED RESULT WAS REPORTED. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PATIENT INTERVENTIONS DUE TO THE DISCORDANT CALCIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 2400 CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSITCS INC. ADVIA 2400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1