BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION CLINICAL CHEMISTRY SYSTEM

    MDR report key: 864678 · Received September 27, 2006

    Report

    Report Number
    2517506-2006-00121
    Event Type
    Malfunction
    Date Received
    September 27, 2006
    Date of Event
    August 26, 2006
    Report Date
    September 8, 2006
    Manufacturer
    DADE BEHRING, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE IFU FOR DIMENSION CTNI FLEX REAGENT CARTRIDGE CONTAINS THE FOLLOWING INFO. "PT 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." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A FALSELY ELEVATED TROPONIN I RESULT OF 0.92 NG/ML WAS OBTAINED. THE SAMPLE WAS RETESTED ON ALTERNATE METHODOLOGY AND A RESULT OF 0.01 NG/ML WAS OBTAINED. THE SAMPLE WAS THEN RERUN ON THE ORIGINAL INSTRUMENT AND A RESULT OF 0.97 NG/ML WAS OBTAINED. THE SAMPLE WAS THEN TREATED WITH NBT AND REPEATED. THE RESULT FROM THE NBT WAS 0.04 NG/ML. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED AND THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES TO THE PT AS A RESULT OF THE FALSELY ELEVATED TROPONIN I RESULTS. ANALYSIS OF SAMPLE INDICATES THAT THE CAUSE OF THE FALSELY ELEVATED TROPONIN I RESULTS WAS NON SPECIFIC BINDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION CLINICAL CHEMISTRY SYSTEM CTNI FLEX REAGENT CARTRIDGE JJE DADE BEHRING, INC. NA CB7156

    Patients

    Seq Age Sex Outcome Treatment
    1 YR