BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS ACCUTNI

    MDR report key: 3930717 · Received July 12, 2014

    Report

    Report Number
    2122870-2014-00511
    Event Type
    Malfunction
    Date Received
    July 12, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 18, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K021814
    Adverse Event
    Yes
    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 ACCUTNL 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. (B)(6). ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS INCIDENT: 2122870-2014-00506, 2122870-2014-00507, 2122870-2014-00508, 2122870-2014-00509, 2122870-2014-00510, 2122870-2014-00511.

    Description of Event or Problem · 1

    THE AFFILIATE STATED THE CUSTOMER REPORTED FALSE POSITIVE TROPONIN I (ACCESS ACCUTNL) RESULTS, FOR SIX PATIENTS, INVOLVING THE ACCESS ACCUTNL ASSAY USED IN CONJUNCTION WITH THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THIS REPORT IS SIX OF SIX REFERENCING THE PATIENT ON THE EVENT DATE NOTED. AN INITIAL RESULT OF 0.437 UG/L WAS OBTAINED AND RELEASED OUT OF THE LABORATORY. AS A RESULT, THE PATIENT WAS TREATED WITH HEPARIN. THE CUSTOMER REANALYZED THE SAMPLE, ON THE SAME INSTRUMENT, AND OBTAINED LOWER RESULTS OF 0.209, 0.042, 0.251, AND 0.014 UG/L. AN AMENDED REPORT WAS ISSUED TO THE HOSPITAL, AND THE PHYSICIAN DISCONTINUED THE HEPARIN TREATMENT. THERE HAS BEEN NO REPORT OF CURRENT PATIENT CONDITION TO DATE. THE PATIENT'S SAMPLE WAS CENTRIFUGED AT 300G (RELATIVE CENTRIFUGAL FORCE) FOR TEN MINUTES, AT 20 DEGREES CELSIUS. NO SAMPLE INTEGRITY ISSUES WERE NOTED. ALL OF THE SAMPLES WERE ALIQUOTED AND RE-CENTRIFUGED AFTER THE INITIAL TEST. THE CUSTOMER INDICATED ALL OF THE SYSTEM PARAMETERS (QUALITY CONTROL, CALIBRATION, AND SYSTEM CHECK) WERE WITHIN SPECIFICATIONS. NO SYSTEM ISSUES WERE OBSERVED AT THE TIME OF THE EVENT. THE INSTRUMENT WAS IN NORMAL OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408548 ACCESS ACCUTNI IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER NA 337598

    Patients

    Seq Age Sex Outcome Treatment
    1 Other