BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 1800

    MDR report key: 3940757 · Received July 17, 2014

    Report

    Report Number
    2432235-2014-00444
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 24, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE CSE PERFORMED PREVENTIVE MAINTENANCE AND REPLACED THE CALCIUM REAGENT. THE CAUSE OF THE DISCORDANT, FALSELY LOW CALCIUM RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY LOW CALCIUM RESULTS WERE OBTAINED ON THREE PATIENT SAMPLES ON AN ADVIA 1800 INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIANS(S), WHO QUESTIONED THEM. THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT, RESULTING HIGHER. IT IS UNKNOWN IF THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW CALCIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417938 ADVIA 1800 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800

    Patients

    Seq Age Sex Outcome Treatment
    1