BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA (R) CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2002652 · Received February 28, 2011

    Report

    Report Number
    2517506-2011-00024
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    January 8, 2011
    Report Date
    January 12, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    MMI
    PMA / PMN Number
    K063756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE IFU FOR THE DIMENSION VISTA CTNI 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." SIEMENS HEALTHCARE DIAGNOSTICS INC. ANALYZED THE DATA FROM THE PATIENT (AS WELL AS PRIOR PATIENT CTNI TESTING HISTORY) AND EVALUATES THE PATTERN OF RESULTS AS CONSISTENT WITH HETEROPHILIC INTERFERENCE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A SERIES OF FALSELY ELEVATED TROPONIN I RESULTS WAS OBTAINED ON A PATIENT'S SAMPLES. THE RESULTS WERE REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULTS. A SERIES OF SAMPLE DRAWS FROM THIS INDIVIDUAL PATIENT WAS RUN EACH DAY FROM (B)(6) 2011 WITH COMPARABLE ELEVATED RESULTS. THE PATIENT SAMPLES WERE RUN ON ALTERNATE SYSTEMS WHICH CONFIRMED THE CARDIAC DISEASE BUT DID NOT EXPLAIN THE LACK OF CHARACTERISTIC RISE AND FALL OF VALUES ON SEQUENTIAL SAMPLING. PATIENT TREATMENT WAS NOT REPORTED TO HAVE BEEN ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED TROPONIN I RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION VISTA (R) CLINICAL CHEMISTRY SYSTEM CARDIAC TROPONIN I FLEX® REAGENT CARTRIDGE MMI SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW 10273AG

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR