BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DADE RXL

    MDR report key: 1403044 · Received June 4, 2009

    Report

    Report Number
    1403044
    Event Type
    Malfunction
    Date Received
    June 4, 2009
    Date of Event
    May 27, 2009
    Report Date
    June 4, 2009
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US

    Narratives

    Description of Event or Problem · 1

    ER PHYSICIAN CALLED AND NOTIFIED THE LAB DIRECTOR THAT HE THOUGHT WE WERE HAVING TROUBLE WITH OUR TROPONINS. TROPONIN I RESULTS WERE FALSELY ELEVATED, RESULTING IN A PATIENT BEING TRANSFERRED FROM OUR FACILITY TO ANOTHER FOR CARDIAC CATHERIZATION. UPON ARRIVAL AT OTHER FACILITY, TROPONIN I PERFORMED WITH A NEGATIVE RESULT BEING OBTAINED. CARDIAC CATHERIZATION NOT PERFORMED. DURING THE RESOLUTION PROCESS, WE DISCOVERED A PRECISION PROBLEM WITH THE INSTRUMENTATION AND HAD THE INSTRUMENT DECONTAMINATED. RECALIBRATION OF THE ASSAY WAS PERFORMED AND QUALITY CONTROL WAS ACCEPTABLE. NO SHIFTS IN QUALITY CONTROL WERE NOTED PRIOR TO NOTIFICATION OF A SUSPECTED PROBLEM BY THE ER PHYSICIAN. PATIENTS WERE REPEATED ON ALTERNATE ANALYZER AND AMENDED REPORTS WERE ISSUED. TROPONIN I TESTING WAS DISCONTINUED ON PATIENTS UNTIL PROBLEM WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DADE RXL CHEMISTRY ANALYZER MMI SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS DADE DIMENSION RXL BC0069

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR
    2 58 YR
    3 58 YR