BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CHEMISTRY LIPASE METHOD

    MDR report key: 1054646 · Received May 29, 2008

    Report

    Report Number
    2432235-2008-00039
    Event Type
    Other
    Date Received
    May 29, 2008
    Date of Event
    April 2, 2008
    Report Date
    April 2, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    CHI
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE SITE TO TROUBLESHOOT THE INSTRUMENT. THE FSE NOTED THAT SEVERAL OF THE CUSTOMER ACCESSIBLE PARAMETERS WERE INCORRECT AND CAUSED THE DISCREPANT LIPASE RESULT. AFTER THE PARAMETERS WERE CORRECTED, THE SYSTEM WAS RE-CALIBRATED. THE QUESTIONABLE LIPASE SAMPLE WAS RE-RUN AND THE EXPECTED RESULT WAS OBTAINED. THE SYSTEM IS OPERATIONAL AND FUNCTIONS AS INTENDED. NO FURTHER EVAL OF THE SYSTEM IS REQUIRED. THE INSTRUMENTS PERFORMANCE IS WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A DISCORDANT ADVIA CHEMISTRY 1650 LIPASE PT RESULT (53 U/L) TO THE CLINICIAN. THIS RESULT WAS QUESTIONED BY THE CLINICIAN BECAUSE THE PATIENT'S AMYLASE WAS >2,000 U/L. THE PT SAMPLE WAS DILUTED, AND A LIPASE RESULT OF 12,000 U/L WAS OBTAINED. THE CUSTOMER STATES THAT QC WAS IN RAGE WITH NO OUTLIERS. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THIS DISCORDANT LIPASE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CHEMISTRY LIPASE METHOD LIPASE METHOD CHI SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA 1650 SYSTEM REAGENT LOT 125000

    Patients

    Seq Age Sex Outcome Treatment
    1