BEUDAMED
    FDA Adverse Event Summary report: N

    ADVIA 1800

    MDR report key: 2040397 · Received April 5, 2011

    Report

    Report Number
    2432235-2011-00049
    Date Received
    April 5, 2011
    Date of Event
    March 19, 2011
    Report Date
    March 20, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K990346
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. THE FSE PERFORMED THE TOTAL SERVICE CALL TO VERIFY THE WASH STATION OPERATION AND PROBE AND MIXER ADJUSTMENTS. THE FSE FOUND SMALL BUBBLES IN THE RRV OIL THIS WAS DUE TO THE STRAW BEING PULLED OUT FROM THE OIL BOTTLE. NO ACTUAL CONCLUSION CAN BE MADE AS TO WHAT SPECIFICALLY CORRECTED THE PROBLEM. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT ADVIA 1800 CREATININE AND UREA RESULTS WERE OBTAINED ON A PATIENT SAMPLE FROM (B)(6) 2011. THE RESULTS WERE REPORTED TO THE PHYSICIAN. UPON RETEST THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE WERE NO REPORT OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CREATININE AND UREA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 1800 CHEMISTRY ANALAYZER, PRODUCT CODE: JJE SIEMENS HEALTHCARE DIAGNOSTICS ADVIA 1800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1