BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2851802 · Received November 29, 2012

    Report

    Report Number
    2122870-2012-01960
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 29, 2012
    Report Date
    November 1, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) REPLACED AND CALIBRATED THE INCUBATOR BELT, AND REPLACED THE MIXER PULLEYS AND MIXER BELT. THE FSE INSPECTED AND CLEANED THE ANALYTICAL MODULE AND WASH CAROUSEL AND PERFORMED ALIGNMENTS. THE FSE REPLACED THE PRECISION PUMP SEALS, O-RING, AND TIMING BELT. THE FSE NOTED THE LUMINOMETER WIRING HARNESS DAMAGED AND REPLACED THE HARNESS. THE FSE WAS UNABLE TO GET THE ULTRASONICS WITHIN SPECIFICATIONS AND REPLACED THE ULTRASONICS. THE FSE REPLACED THE SUBSTRATE PROBE AND PERFORMED A PREVENTIVE MAINTENANCE (PM) MAJOR. THE FSE PERFORMED SYSTEM CHECK, HIGH SENSITIVITY SYSTEM CHECK AND 20-REPLICATE PRECISION TEST; ALL DIAGNOSTIC TESTS RESULTS PASSED WITHIN SPECIFICATIONS. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS. THE CUSTOMER STATED QUALITY CONTROL (QC) WAS WITHIN THE LABORATORY'S ESTABLISHED LIMITS PRIOR TO AND AFTER THE EVENT. QUALITY CONTROL DATA PROVIDED BY THE CUSTOMER IDENTIFIED SEVERAL QC REPLICATES OUTSIDE LIMITS. HOWEVER, THE CUSTOMER REPEATED QC UNTIL OBTAINING AN ACCEPTABLE VALUE. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS EVENT: 2122870-2012-01958, 2122870-2012-01959, 2122870-2012-01960, 2122870-2012-01961, 2122870-2012-01962.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUS TROPONIN I (ACCESS ACCUTNI) RESULTS, FOR TWO PATIENTS, INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER-SUPPLIED DATA INDICATES A TOTAL OF SEVEN PATIENT SAMPLES WITH IMPRECISION RESULTS, ON SEPARATE DAYS. THIS IS REPORT THREE OF FIVE. THE CUSTOMER STATED ALL TESTING WAS PERFORMED ON THE PRIMARY SAMPLE TUBE. THE ERRONEOUS RESULTS WERE NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT. THE CUSTOMER USES A REFERENCE LEVEL OF 0.10 NG/ML AS AN INDICATION TO CARDIAC ISSUES. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1