BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2508318 · Received March 28, 2012

    Report

    Report Number
    2122870-2012-00937
    Event Type
    Malfunction
    Date Received
    March 28, 2012
    Date of Event
    March 3, 2012
    Report Date
    March 5, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    KXT
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) PERFORMED INVESTIGATION AND NOTED LEVEL SENSE FAILURES. THE FSE PERFORMED PREVENTIVE MAINTENANCE (PM) AND RETURNED THE UNIT TO NORMAL OPERATION. THE UNIT CONFORMED TO THE MANUFACTURER'S PERFORMANCE SPECIFICATIONS. CONTROLS WERE PERFORMED PRIOR TO ANALYZING PATIENT SAMPLE. TWO OUT OF THREE CONTROLS WERE IN RANGE. QUALITY CONTROL (QC) IS PERFORMED EVERY 8 HOURS, BUT WAS NOT PERFORMED AFTER THIS PATIENT SAMPLE AS IT WAS PERFORMED ON A DIFFERENT UNIT. PATIENT SAMPLES WERE CENTRIFUGED FOR TEN MINUTES AT A ROOM TEMPERATURE AT 2,500 RPM (REVOLUTIONS PER MINUTE). THE CUSTOMER INDICATED SYSTEM CHECK AND ALL PARAMETERS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUSLY ELEVATED DIGOXIN RESULT, ABOVE THE THERAPEUTIC RANGE, FOR ONE PATIENT, INVOLVING ACCESS 2 IMMUNOASSAY SYSTEM. PER THE LABORATORY'S REPEAT PROTOCOL, SUBSEQUENT TESTING OF THE PATIENT SAMPLE ON THE ORIGINAL AND AN ALTERNATE ACCESS 2 SYSTEM RECOVERED LOWER RESULTS WITHIN THE THERAPEUTIC RANGE. ANOTHER SAMPLE WAS REDRAWN AND ANALYZED ON THE ORIGINAL ACCESS 2 SYSTEM AND RECOVERED A RESULT OF 1.2 NG/ML. DURING THIS TIME, THE CUSTOMER HEARD A CLUNKING SOUND IN THE SYSTEM AND OBTAINED AN ULTRASONICS ERROR. THE ERRONEOUS RESULT WAS NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) ASSESSED THE UNIT AT THE FACILITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR ACCESS 2 IMMUNOASSAY SYSTEM| ACCESS DIGOXIN| ACCESS DIGOXIN CALIBRATORS