BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2202148 · Received August 5, 2011

    Report

    Report Number
    2122870-2011-02694
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    June 5, 2008
    Report Date
    June 6, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Removal / Correction Number
    Z-0914-2010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) SERVICED THE UNIT AT THE FACILITY ON (B)(6) 2008 AND DISCOVERED THE PERI-TUBING IN THE PERISTALTIC PUMP SPLIT. THE FSE REPLACED ALL PERI-TUBING AND THE PERISTALTIC PUMP ON THE UNIT. THE FSE COMPLETED SYSTEM VERIFICATION TESTING, AND THE UNIT CONFORMED TO THE MFR'S PUBLISHED SPECIFICATIONS. QUALITY CONTROL (QC) WAS PERFORMED AT THE BEGINNING OF THE EVENING SHIFT. ALL QC WAS WITHIN RANGE. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED FROM (B)(6), 2008 THROUGH (B)(6), 2010 FOR ADD'L REPORTABLE EVENTS. THIS MEDWATCH REPORT IS RELATED TO MDRS: 2122870-2011-02622, 02690, 02692, 02693.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ELEVATED TROPONIN I (ACCUTNI) RESULTS FOR FIVE PATIENTS INVOLVING UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. TWO PATIENTS WERE ADMITTED TO THE HOSPITAL FROM THE EMERGENCY ROOM (ER). TWO PATIENTS WERE TRANSPORTED TO HIGHER-LEVEL CARE AREAS, AND ONE PT HAD SURGERY DELAYED. THIS REPORT REFERS TO PT NUMBER FIVE OF FIVE. THE ELEVATED RESULTS DID NOT CORRELATE WITH ACCESS 2 IMMUNOASSAY SYSTEM. THE ERRONEOUS RESULTS WERE RELEASED OUT OF THE LABORATORY AND QUESTIONED. THERE HAS BEEN NO REPORT OF PT INJURY. A CHANGE IN PT TREATMENT WAS ASSOCIATED WITH THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY AND ASSESSED TO THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other ACCESS 2 IMMUNOASSAY SYSTEM