BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2840302 · Received November 20, 2012

    Report

    Report Number
    2517506-2012-00323
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    September 4, 2012
    Report Date
    October 26, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    MTF
    PMA / PMN Number
    P000021/S002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED TPSA RESULT IS UNKNOWN. THE ISSUE APPEARS TO BE SAMPLE SPECIFIC FOR THIS ONE PATIENT SINCE THE DISCORDANT RESULTS ARE LIMITED TO THIS INDIVIDUAL PATIENT'S SAMPLES ON TWO DIFFERENT DRAWS. THE IFU FOR DIMENSION TPSA FLEX REAGENT CARTRIDGE CONTAINS THE FOLLOWING INFORMATION: "PATIENT SAMPLES MAY CONTAIN HETEROPHILIC ANTIBODIES THAT COULD REACT IN IMMUNOASSAYS TO GIVE FALSELY ELEVATED OR DEPRESSED RESULTS. THIS ASSAY HAS BEEN DESIGNED TO MINIMIZE INTERFERENCE FROM HETEROPHILIC ANTIBODIES. NEVERTHELESS, COMPLETE ELIMINATION OF THIS INTERFERENCE CANNOT BE GUARANTEED. A TEST RESULT THAT IS INCONSISTENT WITH THE CLINICAL PICTURE AND PATIENT HISTORY SHOULD BE INTERPRETED WITH CAUTION." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT ELEVATED TPSA RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. A REPEAT DRAW AT A LATER DATE WAS RUN AND A LOWER RESULT WAS OBTAINED. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT ELEVATED TPSA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION® CLINICAL CHEMISTRY SYSTEM TOTAL PROSTATE SPECIFIC ANTIGEN FLEX® REAGENT CARTRIDGE MTF SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW EA3150

    Patients

    Seq Age Sex Outcome Treatment
    1