BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 1800

    MDR report key: 6766664 · Received August 4, 2017

    Report

    Report Number
    2432235-2017-00452
    Event Type
    Malfunction
    Date Received
    August 4, 2017
    Date of Event
    May 1, 2017
    Report Date
    September 7, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    UDI-DI
    00630414534794
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. FILED THE INITIAL MDR ON AUGUST 4, 2017. AUGUST 14, 2017; ADDITIONAL INFORMATION: SIEMENS HEALTHCARE DIAGNOSTICS INC. DETERMINED THAT THE PRECISION TESTS RECOVERED BETTER WHEN THE DILUTION PIPETTING PROBE (DPP) LINE WAS BYPASSED. SIEMENS STOPPED INVESTIGATING AND TROUBLESHOOTING THE ISSUE BASED ON AN AGREEMENT WITH THE CUSTOMER. THE CAUSE OF THE DISCORDANT LOW RESULTS OBTAINED ON MULTIPLE ASSAYS ON THE ADVIA 1800 INSTRUMENT IS UNKNOWN. NO FURTHER EVALUATION OF THIS INSTRUMENT IS REQUIRED.

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE DIAGNOSTICS INC. (SIEMENS) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO DETERMINE THE CAUSE OF THE DISCORDANT LOW RESULTS OBTAINED ON MULTIPLE ASSAYS ON THE ADVIA 1800 INSTRUMENT. THE FSE PERFORMED A SYSTEM DECONTAMINATION, REPLACED THE REACTION TRAY (RRV) CUVETTES, REPLACED ALL PROBES AND PUMP SEALS, CLEANED THE EXTERNAL PHOTOMETER LENSES, DECONTAMINATED THE DEIONIZED (DI) WATER STATION-INCLUDING THE PIPE LINES, CHECKED AND CLEANED ALL HYDRAULIC LINES AND BOTTLES. THE FSE ALSO PERFORMED MANY PRECISION TESTS AND THE RESULTS DID NOT RECOVER WITHIN EXPECTED RANGES. TO ISOLATE THE CAUSE OF THE ISSUE TO THE DILUTION PIPETTING PROBE (DPP) LINE, THE FSE DILUTED A SAMPLE AND FIXED THE DILUTED SAMPLE CUP AT THE SAMPLE PIPETTING PROBE (SPP) ASPIRATION POSITION AFTER DISCONNECTING THE DILUTION TRAY WASH UNIT (DWUD) AND REMOVING THE DILUTION TRAY TURNTABLE (DTT). THE FSE PERFORMED A PRECISION TEST AND THE RESULTS RECOVERED WELL. THE FSE INSPECTED THE DTT LINE AND FOUND NO ISSUES. SIEMENS IS INVESTIGATING THE ISSUE.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY LOW CALCIUM (CA), CREATININE (CREA), AND DIRECT BILIRUBIN (DBIL) PATIENT SAMPLE RESULTS WERE OBTAINED ON AN ADVIA 1800 INSTRUMENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE SAME PATIENT SAMPLE(S) WERE RE-RUN ON AN ALTERNATE DIMENSION EXL SYSTEM, RESULTING HIGHER. THE REPEATED RESULTS ALIGNED WITH THE PATIENT'S CLINICAL HISTORY AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW CA, CREA, AND DBIL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546696 ADVIA 1800 ADVIA 1800 JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800 00630414534794

    Patients

    Seq Age Sex Outcome Treatment
    1