BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS ACCUTNI

    MDR report key: 3946000 · Received July 21, 2014

    Report

    Report Number
    2122870-2014-00518
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 25, 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. (B)(6). THIS MEDWATCH REPORT IS RELATED TO MDR 2122870-2014-00517.

    Description of Event or Problem · 1

    THE AFFILIATE STATED THE CUSTOMER REPORTED NON-REPRODUCIBLE, ELEVATED INITIAL TROPONIN I (ACCESS ACCUTNI) RESULTS, ABOVE THE NORMAL REFERENCE RANGE, FOR SEVERAL PATIENTS, INVOLVING THE ACCESS ACCUTNI ASSAY USED IN CONJUNCTION WITH THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THIS REPORT IS TWO OF TWO REFERENCING THE PATIENT ON THE EVENT DATE NOTED. THE INITIAL RESULT WAS RELEASED OUT OF THE LABORATORY AND QUESTIONED BY THE CLINICIAN. THE CLINICIAN REQUESTED REANALYSIS OF THE SAMPLE. THE CUSTOMER RETESTED THE PATIENT'S SAMPLE, ON THE SAME INSTRUMENT, AND OBTAINED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE. IN ADDITION, THE CUSTOMER TESTED THE SAMPLE, THROUGH AN ALTERNATE METHODOLOGY, AND OBTAINED A LOWER, NEGATIVE RESULT. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE PATIENT'S SERUM SAMPLE WAS CENTRIFUGED AT 3,000G (RELATIVE CENTRIFUGAL FORCE) FOR TEN MINUTES, AT 25 DEGREES CELSIUS. THE SAMPLE WAS ANALYZED FROM THE PRIMARY TUBE. NO SAMPLE INTEGRITY ISSUES WERE NOTED. THE CUSTOMER INDICATED ALL OF THE SYSTEM PARAMETERS (QUALITY CONTROL, CALIBRATION, AND SYSTEM CHECK) WERE WITHIN SPECIFICATIONS. THE INSTRUMENT WAS IN NORMAL OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425269 ACCESS ACCUTNI IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER NA 336838

    Patients

    Seq Age Sex Outcome Treatment
    1