BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS ACCUTNI+3 REAGENT

    MDR report key: 3982215 · Received August 5, 2014

    Report

    Report Number
    2122870-2014-00562
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 11, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K121214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION THAT THE ACCESS ACCUTNI+3 DEVICE WAS RETURNED FOR EVALUATION. SERVICE WAS NOT DISPATCHED AS THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. IN CONCLUSION, A DEFINITIVE CAUSE OF THE INCIDENT COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ERRONEOUSLY ELEVATED TROPONIN I (ACCESS ACCUTNI+3) RESULT, ABOVE THE NORMAL REFERENCE RANGE, FOR ONE PATIENT, INVOLVING THE ACCESS ACCUTNI+3 REAGENT USED IN CONJUNCTION WITH THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. AN INITIAL RESULT OF 0.58 NG/ML WAS OBTAINED BUT WAS NOT RELEASED OUT OF THE LABORATORY. SUBSEQUENT TESTING OF THE PATIENT'S SAMPLE, ON THE SAME INSTRUMENT, RECOVERED LOWER RESULTS OF 0.11 NG/ML AND 0.03 NG/ML. THERE WAS NO PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT. THE LABORATORY'S TROPONIN I CUTOFF IS 0.04 NG/ML. THE PATIENT'S SAMPLE WAS COLLECTED IN A LITHIUM HEPARIN PLASMA TUBE WITH GEL AND CENTRIFUGED ON THE AUTOMATION LINE. THE SAMPLE WAS ANALYZED FROM THE PRIMARY TUBE AS STAT AND WAS NOT STORED. THE SAMPLE WAS CLEAR IN APPEARANCE. NO SAMPLE INTEGRITY ISSUES WERE NOTED. THE CUSTOMER STATED QUALITY CONTROL (QC) WAS IN RANGE PRIOR TO AND FOLLOWING THE EVENT. NO SYSTEM ISSUES WERE NOTED. THE INSTRUMENT WAS IN NORMAL OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457259 ACCESS ACCUTNI+3 REAGENT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER NA 337132

    Patients

    Seq Age Sex Outcome Treatment
    1