BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 4210558 · Received October 29, 2014

    Report

    Report Number
    2517506-2014-00282
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 9, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    MMI
    PMA / PMN Number
    K063756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE MOST LIKELY CAUSE FOR THE DISCORDANT ELEVATED TROPONIN I RESULT (RELATIVE TO THE ALTERNATE METHODOLOGY) IS HETEROPHILIC ANTIBODY BINDING. THE PRESENCE OF HETEROPHILIC ANTIBODIES WAS NOT, HOWEVER, CONFIRMED BY INDEPENDENT TESTING FOR HETEROPHILIC ANTIBODY IN SIEMENS TECHNICAL SOLUTIONS LABORATORY TESTING. HOWEVER, THE PATTERN OF DISCREPANCY OF MMB RESULTS ON THE SAME SAMPLE CONFIRMS SAMPLE SPECIFIC ISSUES. HETEROPHILIC ANTIBODY WAS CONFIRMED FOR MMB. THE INSTRUCTIONS FOR USE FOR THE CARDIAC TROPONIN I 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

    AN ELEVATED TROPONIN I RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA. THE RESULT WAS REPORTED TO THE PHYSICIAN. THE PATIENT'S SAMPLE WAS TESTED ON AN ALTERNATE METHODOLOGY AT AN ALTERNATE FACILITY AND NEGATIVE TROPONIN I RESULTS WERE OBTAINED. THE PATIENT WAS SENT TO AN ALTERNATE FACILITY FOR OBSERVATION AND SUBSEQUENT TESTING. IT IS UNKNOWN IF PATIENT TREATMENT WAS NOT OTHERWISE ALTERED OR PRESCRIBED ON THE BASIS OF THE ELEVATED TROPONIN I RESULT ON THE DIMENSION VISTA. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE ELEVATED TROPONIN I RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691375 DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM CARDIAC TROPONIN I FLEX® REAGENT CARTRIDGE MMI SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW 14230BA

    Patients

    Seq Age Sex Outcome Treatment
    1