BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2098105 · Received May 20, 2011

    Report

    Report Number
    2122870-2011-01419
    Event Type
    Injury
    Date Received
    May 20, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 27, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2011, THE FIELD SERVICE ENGINEER (FSE) PERFORMED HSINC52 AND HSLWSON ACTIVITIES. A HSINC52 ASSESSMENT TESTS REACTION VESSEL MOVEMENT THROUGH THE INCUBATOR TRACK (INCUBATION) TO DETECT SPLASHING. A HSLWSON ASSESSMENT TESTS THE WASTE SYSTEM. NO HARDWARE ISSUES WERE INDICATED. NO ROOT CAUSE CAN BE DETERMINED TO DATE.

    Additional Manufacturer Narrative · 1

    THE CLASSIFICATION PRODUCT CODE OF THE SUSPECT MEDICAL DEVICE INVOLVED WAS INCORRECTLY IDENTIFIED AS CGN IN THE ORIGINAL 3500A. THE CORRECT CLASSIFICATION PRODUCT CODE IS JJE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 AN ERRONEOUS, ELEVATED TROPONIN (TROPI) RESULT WITHIN THE RISK STRATIFICATION RANGE WAS GENERATED FOR ONE PATIENT SAMPLE RUN ON THE ACCESS 2 IMMUNOASSAY SYSTEM. THE ELEVATED TROPI RESULT WAS RELEASED FROM THE LABORATORY AND THE PATIENT WAS ADMITTED INTO THE HOSPITAL BASED UPON THIS RESULT. IT IS UNKNOWN WHETHER THERE WAS ANY FURTHER IMPACT TO THE PATIENT, OR THEIR TREATMENT, ASSOCIATED WITH THIS EVENT. MULTIPLE SUBSEQUENT REDRAWS/RETEST RESULTS RECOVERED WITHIN THE NORMAL REFERENCE RANGE. THE INITIAL SAMPLE WAS RETESTED AND IT ALSO RECOVERED WITHIN THE NORMAL REFERENCE RANGE. SYSTEM DATA PROVIDED BY THE CUSTOMER REVEALS THAT THE SYSTEM CHECK PERFORMED ON (B)(4) 2011 WAS WITHIN SPECIFICATIONS. QUALITY CONTROL (QC) RESULTS AND CALIBRATION PASSED SPECIFICATIONS. CUSTOMER QC MEAN AND RANGE SPECIFICATIONS WERE DEEMED APPROPRIATE AS COMPARED TO PEER DATA. THE CUSTOMER STATED THAT INITIAL SAMPLE VERY SLIGHTLY HEMOLYZED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization ACCESS ACCUTNI