BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 1800

    MDR report key: 5752673 · Received June 27, 2016

    Report

    Report Number
    2432235-2016-00348
    Event Type
    Malfunction
    Date Received
    June 27, 2016
    Date of Event
    June 2, 2016
    Report Date
    June 27, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) SPECIALIST WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATING THE INSTRUMENT, THE CSE DISCOVERED THAT THE CUSTOMER RECEIVED NEGATIVE OR NEAR TO ZERO RESULTS ONLY WHEN ASPIRATING FROM A HANGING CUP IN A 10 ML TUBE. THE CSE ADVISED THE CUSTOMER THAT THE CUP SHOULD BE PRESENTED IN A WAY THAT THE TUBE TYPE MATCHES THE PHYSICAL TUBE SO THAT THE SAMPLE DILUTION PROBE (DPP) DRIVES DOWN TO A LEVEL IN THE CUP WHERE THERE IS LIQUID WHEN THE PROBE MOVES VERTICALLY UPWARDS OUT OF THE CUP. THE CUSTOMER SHOULD UTILIZE A DEDICATED TUBE TYPE MATCHED IN THE SOFTWARE SAMPLE CONTAINER SPECIFICATIONS. ADVIA 1800 CHEMISTRY SYSTEM OPERATOR'S GUIDE STATES "MAKE SURE THAT ALL SAMPLE CONTAINERS (INCLUDING TUBE-CUP COMBINATIONS) ARE DEFINED AT THE SYSTEM SPECIFICATION SETTINGS WINDOW TO AVOID PROBE CRASHES." THE ISSUE WAS RESOLVED BY REDUCING THE SENSITIVITY OF DPP PROBE. THE CAUSE OF THE DISCORDANT RESULTS ON PATIENT SAMPLES WAS THAT THE TUBE TYPE DID NOT MATCH THE SOFTWARE SAMPLE CONTAINER SPECIFICATIONS. THIS INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT RESULTS WERE OBTAINED FOR PATIENT SAMPLES ON MULTIPLE ASSAYS ON AN ADVIA 1800 INSTRUMENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT, RESULTING AS EXPECTED. THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406199 ADVIA 1800 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800

    Patients

    Seq Age Sex Outcome Treatment
    1