BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS ACCUTNI

    MDR report key: 3971051 · Received July 31, 2014

    Report

    Report Number
    2122870-2014-00549
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 7, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K021814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION THAT THE ACCESS ACCUTNI 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. THIS MEDWATCH REPORT IS RELATED TO MDR 2122870-2014-00550.

    Description of Event or Problem · 1

    THE AFFILIATE STATED THE CUSTOMER REPORTED FALSE POSITIVE INITIAL TROPONIN I (ACCESS ACCUTNI) RESULTS, FOR TWO PATIENTS, INVOLVING THE ACCESS ACCUTNI ASSAY USED IN CONJUNCTION WITH THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THIS REPORT IS ONE OF TWO REFERENCING THE PATIENT ON THE EVENT DATE NOTED. AN INITIAL RESULT OF 0.064 UG/L WAS OBTAINED AND RELEASED OUT OF THE LABORATORY. SUBSEQUENT TESTING OF THE PATIENT'S SAMPLE, ON THE SAME INSTRUMENT, GENERATED RESULTS OF 0.028, 0.014 (ON CENTRIFUGED ALIQUOT), AND 0.193 UG/L (ON UNCENTRIFUGED SAMPLE). AN AMENDED RESULT OF 0.034 UG/L WAS ISSUED TO THE HOSPITAL. THERE WAS NO REPORT OF PATIENT CONSEQUENCE OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER INDICATED SYSTEM ERRORS WERE NOT OBSERVED AT THE TIME OF THE EVENT. THE CUSTOMER DISCARDS ALL TROPONIN REAGENT PACKS AFTER FIVE TO TEN TESTS REMAIN. THE PATIENT'S SAMPLE WAS COLLECTED IN 13X100 ML SERUM TUBE AND CENTRIFUGED AT 3,000G (RELATIVE CENTRIFUGAL FORCE) FOR TEN MINUTES, AT 19 DEGREES CELSIUS. THE SAMPLE WAS CLEAR IN APPEARANCE AND ANALYZED FROM THE PRIMARY TUBE. ALL OF THE SYSTEM PARAMETERS INCLUDING QUALITY CONTROL (QC), CALIBRATION CURVES, AND SYSTEM CHECKS WERE PERFORMING WITHIN ASSAY AND INSTRUMENT SPECIFICATIONS PRIOR TO AND AFTER THE EVENTS. THE INSTRUMENT WAS IN NORMAL OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448209 ACCESS ACCUTNI IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER NA 337598

    Patients

    Seq Age Sex Outcome Treatment
    1