BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2260814 · Received September 22, 2011

    Report

    Report Number
    2122870-2011-03998
    Event Type
    Malfunction
    Date Received
    September 22, 2011
    Date of Event
    August 23, 2011
    Report Date
    August 25, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JHS
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SAMPLES WERE COLLECTED IN PLASMA SEPARATOR TUBES AND CENTRIFUGED FOR 6 MINUTES AT 5000 RPM OR PROCESSED THROUGH THE AUTOMATION LINE. QUALITY CONTROL WAS PERFORMING WITHIN THE CUSTOMER'S ESTABLISHED LIMITS ON THE DATE OF THE EVENT. PER THE FIELD SERVICE ENGINEER (FSE)'S REQUEST, THE CUSTOMER PERFORMED A SYSTEM CHECK ON (B)(6) 2011. THE CHECK FAILED TO PASS WITHIN INSTRUMENT SPECIFICATIONS. THE FSE COMPLETED A PREVENTIVE MAINTENANCE (PM) UPON ARRIVAL AT THE SITE. THE FSE THEN PERFORMED A HIGH SENSITIVITY SYSTEM CHECK AND CARRY OVER TESTING. ALL PASSED WITHIN INSTRUMENT SPECIFICATIONS. MDRS ASSOCIATED WITH THIS EVENT: 2122870-2011-03998, 2122870-2011-04011.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT OBTAINING AN ERRONEOUSLY ELEVATED CREATINE KINASE-MB (CKMB) RESULT ABOVE THE NORMAL REFERENCE RANGE OF THE ASSAY FOR ONE (1) PATIENT DURING THE PERIOD FROM (B)(6) 2011. THE RESULTS WERE GENERATED ON A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, USED IN CONJUNCTION WITH ACCESS CKMB REAGENT (LOT 023761) AND ACCESS CKMB CALIBRATORS (LOT 022298). THIS REPORT IS ONE OF TWO AND REPRESENTS THE ERRONEOUS RESULT GENERATED ON (B)(6) 2011. THE INITIAL CKMB RESULT WAS REPORTED OUT OF THE LABORATORY. REPEAT TESTING OF THE PATIENT SAMPLE ON THE SAME INSTRUMENT GENERATED A LOWER RESULT THAT WAS WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY. THE INITIAL REPORT WAS AMENDED WITH THIS RESULT. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI 800 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JHS BECKMAN COULTER, INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR