BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1905157 · Received November 22, 2010

    Report

    Report Number
    2122870-2010-00768
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 21, 2010
    Report Date
    November 22, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES ON (B)(6) 2010. SYSTEM CHECK DURING THIS EVENT MET SPECIFICATIONS. THE CUSTOMER IS NOT QUESTIONING ANY OTHER PATIENT RESULTS. THE PATIENT'S SAMPLE WAS SENT TO BECKMAN COULTER CUSTOMER PRODUCT LINE SUPPORT (CPLS) FOR FURTHER TESTING. CPS DUPLICATED THE CUSTOMER'S NEAT ACCUTNI RESULTS ON THE PATIENT'S SAMPLES. ADDITIONAL TESTING USING A MIXTURE OF INTERFERENCE ELIMINATING PROTEINS TO LOOK FOR ANY OBSERVABLE CHANGE IN ANALYTE CONCENTRATIONS INDICATED THE PRESENCE OF A HETEROPHILE LIKE INTERFERENCE. A HETEROPHILE LIKE ANTIBODY IS THE ROOT CAUSE FOR THIS EVENT. SERVICE WAS NOT DISPATCHED FOR THIS EVENT SINCE THE QUESTIONED RESULTS ARE ISOLATED TO ONE PATIENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING REPRODUCIBLE ELEVATED TROPONIN (ACCUTNI) RESULTS, ABOVE THE AMI CUT OFF, GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM ON SEVERAL SAMPLES FROM ONE PATIENT. THE RESULTS WERE REPORTED OUT OF THE LAB AND PHYSICIAN QUESTIONED THE RESULTS AS THEY DID NOT CORRELATE WITH THE PATIENT'S CLINICAL PICTURE. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION ON (B)(6) 2010. NO OTHER CHANGE TO PATIENT TREATMENT WAS REPORTED.

    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 IMMUNOASSAY SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization