BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2902470 · Received January 8, 2013

    Report

    Report Number
    2122870-2013-00007
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 8, 2012
    Report Date
    December 10, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S SAMPLE WAS COLLECTED IN A HEPARINIZED PLASMA TUBE WHICH WAS CENTRIFUGED FOR TWO MINUTES AT 7200 RPM. THE CUSTOMER NOTED THAT THE SAMPLE WAS A FULL DRAW WITH NO SIGNS OF HEMOLYSIS OR LIPEMIA. ADDITIONALLY, ASSAY QC HAS BEEN PERFORMING WITHIN THE LABORATORY'S ESTABLISHED RANGES. A ROUTINE SYSTEM CHECK PERFORMED ON (B)(4) 2012, PASSED WITHIN INSTRUMENT SPECIFICATIONS AND THERE HAS BEEN NO ERRORS POSTED TO THE EVENT LOG IN CONJUNCTION WITH THIS EVENT. THE CUSTOMER HAD THEIR OWN ON-SITE BIO-MEDICAL ENGINEER (BME) PERFORM AN INSTRUMENT VALIDATION. ACCORDING TO THE CUSTOMER'S RECORDS THE BME PERFORMED A MAJOR PREVENTIVE MAINTENANCE (PM) ON THE INSTRUMENT INCLUDING REPLACING THE ROTORS, STATORS AND SEALS IN THE WASH AND PRECISION PUMPS AND REPLACING THE INCUBATOR BELT. THE BME PERFORMED A ROUTINE SYSTEM CHECK AND A HIGH SENSITIVITY SYSTEM CHECK BOTH OF WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. THE BME ALSO PERFORMED AN ACCUTNI PRECISION TEST WHICH PASSED WITHIN THE ASSAY'S STATED PRECISION CLAIM. IN CONCLUSION, THERE IS NO EVIDENCE TO SUGGEST THAT AN INSTRUMENT MALFUNCTION WAS THE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) IN REGARDS TO OBTAINING A NON-REPRODUCIBLE HIGHER THAN EXPECTED TROPONIN (ACCUTNI) RESULT WITHIN THE RISK STRATIFICATION RANGE FOR ONE (1) PATIENT ON THE ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER STATED THE ORIGINAL RESULT OBTAINED WAS 0.07 NG/ML. THIS RESULT WAS RELEASED FROM THE LABORATORY AND THE PATIENT WAS SUBSEQUENTLY HOSPITALIZED. THE CUSTOMER NOTED THAT SINCE THE ORIGINAL RESULT WAS WITHIN THE RISK STRATIFICATION RANGE THE CUSTOMER REANALYZED THE SAMPLE ON THE LABORATORY'S ALTERNATE INSTRUMENT WHICH PRODUCED A RESULT OF 0.01 NG/ML. THE PATIENT WAS DRAWN AGAIN FOUR HOURS LATER AND A RESULT OF 0.01 NG/ML WAS OBTAINED AT THAT TIME. THE ORIGINAL PATIENT REPORT WAS CORRECTED. IT IS UNKNOWN WHETHER THE PATIENT UNDERWENT ANY ADDITIONAL MEDICAL PROCEDURES OR TREATMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9630 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER INC. ACCESS 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization