BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS ACCUTNL+3 REAGENT

    MDR report key: 4141246 · Received October 3, 2014

    Report

    Report Number
    2122870-2014-00701
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 11, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    KL121790
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION THAT THE ACCESS ACCUTNL+3 DEVICE WAS RETURNED FOR EVALUATION. THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND DID NOT NOTE ANY SYSTEM ISSUES. THE FSE PERFORMED AN EARLY PREVENTATIVE MAINTENANCE (PM). SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. IN CONCLUSION, A DEFINITIVE CAUSE OF THE INCIDENT COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NON-REPRODUCIBLE, ELEVATED INITIAL TROPONIN I (ACCESS ACCUTNL+3) RESULT, FOR ONE PATIENT, INVOLVING THE ACCESS ACCUTNL+3 REAGENT USED IN CONJUNCTION WITH THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. AN INITIAL RESULT OF 0.19 NG/ML WAS OBTAINED AND RELEASED OUT OF THE LABORATORY. AS RESULT, THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR CARDIAC TESTING. THE CUSTOMER DID NOT HAVE FURTHER PATIENT INFORMATION. THE CUSTOMER WAS UNAWARE OF ANY ADDITIONAL TREATMENT GIVEN TO THE PATIENT. THERE HAS BEEN NO REPORT OF CURRENT PATIENT OUTCOME TO DATE. THE CUSTOMER REANALYZED THE SAMPLE, ON AN ALTERNATE ACCESS 2 SYSTEM, AND OBTAINED A LOWER RESULT OF 0.01 NG/ML WHICH WAS WITHIN THE NORMAL REFERENCE RANGE. THE PATIENT'S SAMPLE WAS COLLECTED IN A LITHIUM HEPARIN TUBE AND CENTRIFUGED AT 8,500 RPM (ROTATIONS PER MINUTE) FOR THREE MINUTES. NO SAMPLE INTEGRITY ISSUES WERE OBSERVED. THE CUSTOMER INDICATED ALL SYSTEM PARAMETERS, INCLUDING QUALITY CONTROL, CALIBRATION, AND SYSTEM CHECK, WERE WITHIN ASSAY AND INSTRUMENT SPECIFICATIONS. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620407 ACCESS ACCUTNL+3 REAGENT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER NA 424514

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization