BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS ACCUTNI+3

    MDR report key: 4201682 · Received October 27, 2014

    Report

    Report Number
    2122870-2014-00724
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 1, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K121790
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE AND PERFORMED A PREVENTATIVE MAINTENANCE ON THE INSTRUMENT. THE FSE THEN PERFORMED INSTRUMENT VERIFICATION AND THE INSTRUMENT FAILED HIGH SENSITIVITY SYSTEM CHECK FOR THE FOAM PORTION. THE FSE THEN REPLACED THE DISPENSE PROBES DURING NORMAL TROUBLESHOOTING AND WAS ABLE TO GENERATE A PASSING SYSTEM CHECK AND HIGH SENSITIVITY SYSTEM CHECK. THERE WAS NO INDICATION OF A SYSTEM MALFUNCTION AS THE CUSTOMER HAD TWO PASSING SYSTEM CHECKS AND A PASSING PRECISION RUN AFTER THE NON-REPRODUCIBLE RESULT WAS GENERATED. THE CUSTOMER SUPPLIED PHOTOGRAPHS OF THE SAMPLE IN QUESTION AND BECKMAN COULTER NOTED THAT THE SAMPLE WAS VERY LIPEMIC AND CONTAINED PARTICULATE MATTER. THERE WAS NO INDICATION THAT THE ACCESS ACCUTNI+3 REAGENT WAS RETURNED FOR EVALUATION. IN CONCLUSION, THE CAUSE OF THE NON-REPRODUCIBLE TNIDX RESULTS IS DUE TO SAMPLE INTEGRITY. THERE IS NO EVIDENCE TO REASONABLY SUGGEST A SYSTEM MALFUNCTION. PER THE ACCESS ACCUTNI+3 REAGENT INSTRUCTIONS FOR USE (IFU), TURBID SERUM OR PLASMA SAMPLES CONTAINING PARTICULATE MATTER SHOULD BE TRANSFERRED FORM THE ORIGINAL TUBE AND RECENTRIFUGED PRIOR TO ASSAY. A SPECIMEN (ORIGINAL TUBE) THAT CONTAINS A SEPARATING DEVICE (GEL BARRIER) IS NEVER TO BE RECENTRIFUGED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING A NON-REPRODUCIBLE ELEVATED ACCESS ACCUTNI+3 (TROPONIN I) RESULT FOR ONE (1) PATIENT FROM THE UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER STATED THAT THE PATIENT WAS TRANSFERRED TO AN ALTERNATE FACILITY, UNDERWENT A CARDIAC CATHETERIZATION PROCEDURE, AND NO ABNORMALITIES WERE NOTED. THE CUSTOMER REPEATED THE SAMPLE AND OBTAINED NEGATIVE RESULTS WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY. THERE WAS NO REPORT OF ANY ADVERSE CONSEQUENCE TO THE PATIENT AS A RESULT OF THE PROCEDURE. ALL SYSTEM PARAMETERS INCLUDING QUALITY CONTROL (QC), CALIBRATION, SYSTEM CHECK AND PRECISION RUN WERE WITHIN ASSAY AND INSTRUMENT SPECIFICATIONS FOLLOWING THE EVENT AND PRIOR TO THE SERVICE VISIT. ALTHOUGH HARDWARE VERIFICATION TESTING DID NOT INDICATE A HARDWARE OR SYSTEM FAILURE, THE CUSTOMER REQUESTED FOR SERVICE TO EVALUATE THE INSTRUMENT. THE ACCESS ACCUTNI+3 REAGENT WAS USED IN CONJUNCTION WITH THE UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681350 ACCESS ACCUTNI+3 IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER NA 337132

    Patients

    Seq Age Sex Outcome Treatment
    1 Other