BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 3882388 · Received June 18, 2014

    Report

    Report Number
    2122870-2014-00444
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    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) REPLACED THE PERISTALTIC PUMP TUBING AND ASPIRATE PROBES. THE FSE CLEANED THE WASH VALVE AND REPLACED THE WASH WHEEL BEARINGS. THE FSE DID NOT OBSERVE ANY ISSUES WITH THESE PARTS. THE FSE COMPLETED A SUCCESSFUL SYSTEM CHECK. THE FSE THEN PERFORMED A 50-REPLICATE PRECISION RUN USING LOW LEVEL 1 QUALITY CONTROL MATERIAL. THE PRECISION RUN FAILED WITH A MEAN OF 0.052 NG/ML, STANDARD DEVIATION (SD) OF 0.008 NG/ML, AND COEFFICIENT OF VARIATION (%CV) OF 16.67%. THE PEER MEAN AT 0.039 NG/ML. THE EXPECTED SD IS LESS THAN (<) 0.006 NG/ML AT CONCENTRATIONS OF LESS (< ) 0.075 NG/ML. THE FSE NOTED THE VOLTAGE FOR THE TRANSDUCER WAS WITHIN RANGE BUT DRIFTED HIGHER WITHOUT STABILIZING. THE FSE REPLACED THE TRANSDUCER. THE FSE COMPLETED A SUCCESSFUL SYSTEM CHECK AND HIGH SENSITIVITY (HS) SYSTEM CHECK. THE FSE NOTED, ALTHOUGH SYSTEM CHECK PASSED, THE SUBSTRATE RLU (RELATIVE LIGHT UNIT) VALUE WAS ELEVATED. THE FSE DECONTAMINATED THE SUBSTRATE SYSTEM AND NOTED THE SUBSTRATE RLU VALUES DID NOT CHANGE. THE FSE ADJUSTED THE LUMINOMETER AND NOTED SYSTEM CHECK PASSED WITH LOWER SUBSTRATE RLU VALUES. THE FSE THEN COMPLETED A SUCCESSFUL 20-REPLICATE PRECISION TEST WITH A MEAN OF 0.041 NG/ML. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. IN CONCLUSION, SYSTEM HARDWARE IS THE LIKELY CAUSE OF THE EVENT AS REPAIRS AND ADJUSTMENTS RESOLVED THE REPORTED ISSUE. HOWEVER, A SPECIFIC HARDWARE COMPONENT WAS NOT IDENTIFIED AS THE SINGULAR CAUSE OF THE EVENT. (B)(6). THIS MEDWATCH REPORT IS RELATED TO MDR 2122870-2014-00443.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ELEVATED, NON-REPRODUCIBLE TROPONIN I (ACCESS ACCUTNI+3) RESULTS, FOR TWO PATIENTS, INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM. THIS REPORT IS TWO OF TWO REFERENCING THE PATIENT ON THE EVENT DATE NOTED. AN INITIAL ELEVATED RESULT OF 0.05 NG/ML WAS OBTAINED. THE SAMPLE WAS REANALYZED, ON AN ALTERNATE ACCESS 2 SYSTEM, AND GENERATED A LOWER RESULT OF 0.003 NG/ML WHICH WAS RELEASED FROM THE LABORATORY. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS EVENT. THE CUSTOMER STATED ELEVATED RESULTS, OBTAINED ON THE ORIGINAL INSTRUMENT, ARE REANALYZED ON THE ALTERNATE ACCESS 2 SYSTEM, PER LABORATORY PROTOCOL. THE PATIENT'S SAMPLE WAS COLLECTED IN 13X75 MM LITHIUM HEPARIN TUBE AND CENTRIFUGED AT 6,000 RPM (ROTATIONS PER MINUTE) FOR FIVE MINUTES, AT AMBIENT CENTRIFUGE TEMPERATURE. NO SAMPLE INTEGRITY ISSUES WERE NOTED. THE SAMPLE WAS ANALYZED FROM AN INSERT CUP. SERVICE WAS REQUESTED AND A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356868 ACCESS 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1