BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA 1650

    MDR report key: 1855235 · Received September 30, 2010

    Report

    Report Number
    2432235-2010-00131
    Event Type
    Other
    Date Received
    September 30, 2010
    Date of Event
    August 31, 2010
    Report Date
    September 1, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JGS
    PMA / PMN Number
    K990346
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. AFTER ANALYZING THE INSTRUMENT AND INSTRUMENT DATA, THE FSE REPLACED DRAIN PUMP 2 AND CLEARED A BLOCKAGE IN THE DILUTION TRAY WASH UNIT DRYER NOZZLE. THE ACTUAL ROOT CAUSE COULD NOT BE DETERMINED AND NO CONCLUSION CAN BE DRAWN AS TO WHAT SPECIFICALLY CORRECTED THE PROBLEM. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT CALCIUM (CA_2) RESULT WAS OBTAINED FOR ONE PT ON AN ADVIA 1650. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS RERUN AND CONFIRMED ON THE SAME INSTRUMENT. THE CORRECTED RESULT WAS REPORTED. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PT INTERVENTION DUE TO THE DISCORDANT CALCIUM (CA_2) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 1650 CHEMISTRY ANALYZER JGS SIEMENS HEALTHCARE DIAGNOSTICS INC ADVIA 1650 NA

    Patients

    Seq Age Sex Outcome Treatment
    1