BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 1650 CHEMISTRY SYSTEM

    MDR report key: 1030786 · Received April 17, 2008

    Report

    Report Number
    2432235-2008-00033
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    March 12, 2008
    Report Date
    March 14, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS MFG LTD
    Product Code
    JJE
    PMA / PMN Number
    K990346
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER EVAL OF THE DEVICE IS REQUIRED. ANALYSIS OF INSTRUMENT INDICATES THAT INTERMITTENT DISCREPANCY RESULT WAS DUE TO SYSTEM MALFUNCTION. A SIEMENS HEALTHCARE DIAGNOSTICS INC. FIELD SERVICE REP WAS DISPATCHED TO THE ACCOUNT AND CORRECTED THE MALFUNCTION. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A FALSELY DEPRESSED URINE PROTEIN RESULT OF 1 MG/DL WAS OBTAINED ON A PT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE ORIGINAL SAMPLE WAS RETESTED AND A RESULT OF 45 MG/DL WAS OBTAINED. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY DEPRESSED URINE PROTEIN RESULT. ANALYSIS OF THE INSTRUMENT INDICATES THAT INTERMITTENT DISCREPANCY RESULT WAS DUE TO SYSTEM MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 1650 CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS MFG LTD ADVIA 1650 NA

    Patients

    Seq Age Sex Outcome Treatment
    1