BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2264689 · Received September 26, 2011

    Report

    Report Number
    2122870-2011-04127
    Event Type
    Injury
    Date Received
    September 26, 2011
    Date of Event
    September 2, 2011
    Report Date
    September 2, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE EVENT APPEARED TO BE SAMPLE RELATED. A PREVIOUS INVESTIGATION WAS PERFORMED BY BECKMAN COULTER INC INVOLVING THE SAME PATIENT AND ASSOCIATED WITH THE GENERATION OF ELEVATED ACCUTNI RESULTS. AS PART OF THE PREVIOUS INVESTIGATION, THE PATIENT SAMPLE WAS RETURNED AND ASSESSED BY BECKMAN COULTER INC CUSTOMER PRODUCT LINE SUPPORT FOR POSSIBLE SAMPLE INTERFERENT. THE RESULT OF THE PREVIOUS INVESTIGATION WAS THAT A PATIENT SOURCE, HETEROPHILE-LIKE INTERFERENT, WAS THE ROOT CAUSE OF THIS EVENT. AS THIS IS THE SAME PATIENT AND THE SAME AFFECTED ASSAY, THE SAME ROOT CAUSE WOULD APPLY TO THIS EVENT. MDRS ASSOCIATED WITH THIS EVENT: 2122870-2011-04127, 2122870-2011-03739.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 ELEVATED, REPRODUCIBLE CARDIAC TROPONIN (ACCUTNI) RESULTS ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) THRESHOLD WERE GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT. AN ELEVATED ACCUTNI RESULT WAS REPORTED OUT OF THE LABORATORY. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO THE ELEVATED ACCUTNI RESULT. UPON REPEAT ON THE SAME INSTRUMENT, THE ACCUTNI RESULT WAS ELEVATED, ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) THRESHOLD, AND CONSISTENT WITH THE INITIAL RESULT BOTH LEVELS OF ACCUTNI QUALITY CONTROL WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES DURING THE TIMEFRAME OF THE EVENT. SAMPLE COLLECTION/HANDLING INFORMATION AS WELL AS ADDITIONAL SYSTEM INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R ACCESS ACCUTNI