BEUDAMED
    FDA Adverse Event Summary report: N

    ADVIA 1650

    MDR report key: 2040396 · Received April 5, 2011

    Report

    Report Number
    2432235-2011-00048
    Date Received
    April 5, 2011
    Date of Event
    March 26, 2011
    Report Date
    March 27, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. THE FSE CHECKED THE SYSTEM OPERATION, ADJUSTED THE WASH STATION, FIXED THE ELECTRICAL CONNECTION ON THE DILUTION PROBE PIPETTE( DPP) AND REPLACED COUPLING. THE FSE RAN QC AND RESULTS WERE GOOD. NO CONCLUSION CAN BE DRAWN AS TO WHAT SPECIFICALLY CAUSED THE PROBLEM. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT ADVIA 1650 POTASSIUM RESULTS WERE OBTAINED ON A PATIENT SAMPLE. THE RESULTS WERE REPORTED TO THE PHYSICIAN. UPON RETEST THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN. THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT POTASSIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 1650 CHEMISTRY ANALAYZER, PRODUCT CODE: JJE SIEMENS HEALTHCARE DIAGNOSTICS ADVIA 1650 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1