BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION CLINICAL CHEMISTRY SYSTEM

    MDR report key: 1000746 · Received February 19, 2008

    Report

    Report Number
    2517506-2008-00016
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    February 6, 2008
    Report Date
    February 6, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LTJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY DEPRESSED PROSTATE SPECIFIC ANTIGEN RESULT WAS SAMPLE INTEGRITY. THE IFU FOR DIMENSION TPSA FLEX REAGENT CARTRIDGE CONTAINS THE FOLLOWING INFORMATION: "SPECIMENS SHOULD BE FREE OF PARTICULATE MATTER TO PREVENT APPEARANCE OF FIBRIN IN SERUM SAMPLES, COMPLETE CLOT FORMATION SHOULD TAKE PLACE BEFORE CENTRIFUGATION." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A FALSELY DEPRESSED PROSTATE SPECIFIC ANTIGEN RESULT OF 0.0 NG/ML WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE ORIGINAL SAMPLE WAS RETESTED AND A RESULT OF 73.79 NG/ML WAS OBTAINED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY DEPRESSED PROSTATE SPECIFIC ANTIGEN RESULTS. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY DEPRESSED PROSTATE SPECIFIC ANTIGEN RESULT WAS SAMPLE INTEGRITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION CLINICAL CHEMISTRY SYSTEM TPSA FLEX REAGENT CARTRIDGE LTJ SIEMENS HEALTHCARE DIAGNOSTICS, INC. NA DS8195

    Patients

    Seq Age Sex Outcome Treatment
    1