BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2973419 · Received February 22, 2013

    Report

    Report Number
    2122870-2013-00152
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 24, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    LTJ
    PMA / PMN Number
    K922823/A007
    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) NOTED LUTEINIZING HORMONE (LH) QUALITY CONTROL (QC) WAS 1-2 STANDARD DEVIATION (SD) BELOW THE MEAN. PRECISION RUN INDICATED A STANDARD DEVIATION OF 0.15 AND PERCENT COEFFICIENT OF VARIATION (%CV) OF 4.68%. THE FSE NOTED FIRST SAMPLE RESULT WAS LOWER INDICATING ULTRASONICS ISSUES. THE FSE REPLACED THE TRANSDUCER AND ULTRASONICS PRINTED CIRCUIT BOARD (PCB), ADJUSTED THE TRANSDUCER TEMPERATURE AND VOLTAGES, AND PERFORMED ALIGNMENTS. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS. THE CUSTOMER STATED PATIENT SAMPLES WERE COLLECTED IN 8.5ML SERUM SEPARATOR TUBES AND CENTRIFUGED AT 3,361 RPM (ROTATIONS PER MINUTE) FOR TEN MINUTES, AT ROOM TEMPERATURE. THE CUSTOMER POURED THE SAMPLES, CHECKED FOR FIBRIN, AND FROZE THE SAMPLES BETWEEN ANALYSES. THE CUSTOMER DOES NOT REPEAT CENTRIFUGATION AFTER THE SAMPLE THAWS. TWO LEVELS OF QUALITY CONTROL (QC) ARE PERFORMED DAILY AND HAD BEEN WITHIN THE ACCEPTABLE RANGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NON-REPRODUCIBLE AND ELEVATED PROSTATE-SPECIFIC ANTIGEN (PSA) RESULTS, FOR TWO PATIENTS, INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM UTILIZED IN CONJUNCTION WITH THE ACCESS HYBRITECH PSA ASSAY. SUBSEQUENT ANALYSIS OF THE PATIENT'S SAMPLE, ON THE SAME ANALYZER, RECOVERED LOWER RESULTS. THE ERRONEOUS RESULTS WERE RELEASED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78707 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE LTJ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1