BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2024576 · Received March 21, 2011

    Report

    Report Number
    2122870-2011-00726
    Event Type
    Injury
    Date Received
    March 21, 2011
    Date of Event
    October 4, 2007
    Report Date
    October 5, 2007
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    922823/A007
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER COLLECTS PLASMA SAMPLES IN 13X100 PLASTIC LITHIUM HEPARIN TUBES WITH GEL. THE CUSTOMER CENTRIFUGES SAMPLES AT 3000 RPM FOR 10 MINUTES AT ROOM TEMPERATURE IN A SWINGING BUCKET CENTRIFUGE. SPECIMENS ARE ROUTINELY SAMPLED FROM THE PRIMARY TUBES. THE CUSTOMER ALLOWED THE SAMPLES TO CLOT FOR 15-20 MINUTES AND THE TUBES WERE INVERTED ACCORDING TO THE MANUFACTURER'S RECOMMENDATIONS, PER THE TYPE 1 SUPPLEMENTAL DATA FORM. THE CUSTOMER SENT SAMPLES TO CPLS FOR FURTHER INVESTIGATION. THE CUSTOMER DOCUMENTED THAT THE LABORATORY USES SMALL FILTERS IN ALL LITHIUM HEPARIN TUBES THAT ACCUTNI TESTING IS ORDERED ON. QC WAS WITHIN SPECIFICATIONS PRIOR TO AND AFTER THE EVENT. A SYSTEM CHECK PERFORMED ON (B)(4) 2007 WAS WITHIN SPECIFICATIONS. THERE WERE NO FLAGS OR ERROR CODES PER THE SUPPLEMENTAL DATA FORM. THE CUSTOMER DID NOT REQUEST SERVICE DUE TO SUSPECTING HETEROPHILE INTERFERENCE FOR THE PATIENT. CUSTOMER PRODUCT LINE SUPPORT TESTED THE PATIENT SAMPLES AND OBTAINED NEAT TROPONIN VALUES OF 0.65 NG/ML(SERUM) AND 0.62NG/ML(PLASMA). DILUTION STUDIES INDICATE NON-LINEAR RECOVERY AND THE ADDITION OF HETEROPHILE BLOCKING AGENTS REDUCED THE NEAT DOSE OF 0.06 NG/ML CONCENTRATION SIGNIFICANTLY. THEREFORE INDICATING THAT THERE IS "HETEROPHILE INTERFERENCE" IN THE PATIENT'S SAMPLES IS THE ROOT CAUSE FOR THE ELEVATED ACCUTNI RESULTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS WITHIN THE DATE RANGE OF (B)(6) 2011 - (B)(6) 2011 FOR ADDITIONAL REPORTABLE EVENT/OCCURRENCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS ELEVATED ACCUTNI RESULTS ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUTOFF FOR ONE PATIENT GENERATED BY THE ACCESS 2 IMMUNOASSAY ANALYZER. THE RESULT WAS REPORTED OUT OF THE LABORATORY AND THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY AND A NEGATIVE TROPONIN RESULT WAS OBTAINED VIA ALTERNATE METHOD. THE CUSTOMER DID NOT PROVIDE THE EXACT TROPONIN VALUE OR METHODOLOGY. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR EVALUATION. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY OR DEATH ATTRIBUTED OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER INC. ACCESS 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization