BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA(R) CLINICAL CHEMISTRY SYSTEM

    MDR report key: 3874742 · Received June 16, 2014

    Report

    Report Number
    2517506-2014-00062
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    August 25, 2012
    Report Date
    May 19, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    MTF
    PMA / PMN Number
    P000021/S013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCREPANT ELEVATED TPSA RESULTS RELATIVE TO ALTERNATE TESTING METHODOLOGIES IS UNKNOWN. THE PATTERN OF ELEVATED (NON-NEGATIVE) RESULTS POST-PROSTATECTOMY IS HIGHLY SUGGESTIVE OF NON-SPECIFIC HETEROPHILIC ANTIBODY BINDING SPECIFIC TO THE INDIVIDUAL PATIENT. THE DIMENSION VISTA(R) TPSA FLEX(R) REAGENT CARTRIDGE INSTRUCTIONS FOR USE STATES: 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 FROM ALL PATIENT SPECIMENS CANNOT BE GUARANTEED. A TEST RESULT THAT IS INCONSISTENT WITH THE CLINICAL PICTURE AND PATIENT HISTORY SHOULD BE INTERPRETED WITH CAUTION. IT IS SIEMENS UNDERSTANDING THAT THE ORIGINAL SURGERY WAS APPROPRIATE BECAUSE HISTOLOGICAL EXAMINATION SHOWED A HIGH-GRADE PROSTATIC ADENOCARCINOMA WITH INFILTRATION. HOWEVER, THE ELEVATED PSA VALUES POST-PROSTATECTOMY ARE NOW QUESTIONED BY THE PATIENT BECAUSE THE ALTERNATE METHOD PSA VALUES ARE NEGATIVE AS WELL AS THE PET/TC. THE PHYSICIAN PROCEEDED TO ADDITIONAL TREATMENT DESPITE THE NEGATIVE PET/TC RESULTS. THE PATIENT HAS DECLINED TO PROVIDE ADDITIONAL SAMPLES FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    A CUSTOMER INQUIRED ABOUT DISCREPANT ELEVATED DIMENSION VISTA(R) TPSA RESULTS OBTAINED ON A POST-PROSTATECTOMY PATIENT RELATIVE TO LOW RESULTS OBTAINED ON AN ALTERNATE METHODOLOGY. THE PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN. ALTHOUGH THE RESULTS WERE DISCORDANT WITH A PET/TC SCAN OBTAINED ON THE PATIENT, THE PHYSICIAN DID NOT QUESTION THE RESULTS. IT WAS ALLEGED THAT THE PATIENT TREATMENT WAS ALTERED ON THE BASIS OF THE RELATIVE ELEVATION OF THE DIMENSION VISTA TPSA RESULTS. THE PATIENT WAS STARTED ON A TREATMENT WITH ELIGARD AND SUBSEQUENT RADIOTHERAPY. THERE IS NO REPORT OF ADVERSE OUTCOME TO THE PATIENT ON THE BASIS OF THE ALTERED THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352731 DIMENSION VISTA(R) CLINICAL CHEMISTRY SYSTEM TOTAL PROSTATE SPECIFIC ANTIGEN FLEX® REAGENT CARTRIDGE MTF SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW

    Patients

    Seq Age Sex Outcome Treatment
    1