BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2121768 · Received May 20, 2011

    Report

    Report Number
    2122870-2011-01290
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    August 7, 2010
    Report Date
    August 7, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    Z-0607-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY AND CONFIRMED THAT THE ACCUTNI REAGENT PACK WAS SHARED WITH ANOTHER ACCESS SYSTEM. THE FSE DETERMINED THAT THE PACK IN USE WAS EMPTY EVEN THOUGH THE REAGENT INVENTORY SHOWED 40 TESTS LEFT. THE FSE SCANNED THE PACK ON THE CUSTOMER'S OTHER ACCESS SYSTEM WHICH SHOWED THE PACK AS DELETED. THIS WOULD INDICATE THAT THE PACK HAD BEEN LOADED AND MOST LIKELY USED BEFORE LOADING ONTO THIS SYSTEM. AS INDICATED IN THE LABELING, REAGENT PACK SHARING BETWEEN SYSTEMS CAN POTENTIALLY CAUSE INACCURATE RESULTS AND IS NOT PERMITTED. USER ERROR IS THE CAUSE OF THE EVENT. NO SAMPLE COLLECTION OR CENTRIFUGATION DATA WAS SUPPLIED. THE CUSTOMER WAS ADVISED BY CUSTOMER TECHNICAL SUPPORT (CTS) TO REPEAT ALL ACCUTNI PATIENTS' SAMPLES THAT MAY HAVE BEEN RUN FROM THIS REAGENT PACK. CTS ADVISED THE CUSTOMER TO COLLECT ARCHIVE DATA FILES AND REPEAT PATIENT TESTING. THE CUSTOMER DECLINED TO SUPPLY ANY DATA OR COLLECT ANY FILES. NO DATA FILE OR SYSTEM CHECK DATA WAS PROVIDED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 TO (B)(4), 2010 FOR ADDITIONAL REPORTABLE EVENTS. THIS MEDWATCH IS RELATED TO THE ORIGINAL MDR 2122870-2010-00489, PATIENT NUMBER ONE. RELATED MDRS: 2122870-2011-01289, 2122870-2011-01291, 2122870-2011-01292.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED INDETERMINATE (IND)/NO VALUE FLAGS RESULTS ON THE QUALITY CONTROL (QC) AND FIVE PATIENTS' SAMPLES FOR TROPONIN (ACCUTNI) INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM. THIS REPORT REFERS TO PATIENT NUMBER THREE. THE CUSTOMER STATED THE LAST FIVE TROPONIN TESTS WERE QC, AND THE PREVIOUS FIVE TESTS WERE PATIENTS' SAMPLES. IT IS UNKNOWN IF THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY OR WHETHER A CHANGE IN PATIENT TREATMENT WAS ASSOCIATED WITH THIS EVENT. A FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY AND ASSESSED THE UNIT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS ACCUTNI