BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 3011826 · Received March 19, 2013

    Report

    Report Number
    2122870-2013-00313
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    DHA
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) OBSERVED AIR WITHIN THE LINE BETWEEN THE PRECISION PUMP AND SAMPLE PIPETTOR AND FLUID MOVING AROUND THE THREADS OF THE PIPETTOR FLUID LINE IN THE OBSTRUCTION DETECTION MANIFOLD (OBSTRUCTION DETECTION HARDWARE MODIFICATION WAS PERFORMED AS PART OF THE PREVENTATIVE MAINTENANCE (PM). THE FSE REPLACED THE FLUID LINE AND FLUID LINE CHAIN. THE FSE PERFORMED TRANSDUCER ADJUSTMENT AND PIPETTOR ALIGNMENTS. THE FSE NOTED THE UPPER PERISTALTIC PUMP CASSETTE WAS NOT COMPLETELY SEATED. THE FSE REPLACED THE LARGER PERISTALTIC PUMP TUBING AND RESEATED THE CASSETTE. THE FSE COMPLETED SYSTEM CHECK, 10-REPLICATE PRECISION TESTING USING THE LOW LEVEL TOTAL BETA HUMAN CHORIONIC GONADOTROPHIN (TBHCG) QUALITY CONTROL MATERIAL, AND ALL LEVELS OF QUALITY CONTROL (QC); ALL RESULTS WERE WITHIN SPECIFICATIONS. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISCREPANT TOTAL BETA HUMAN CHORIONIC GONADOTROPHIN (THCG) AND FOLLICLE-STIMULATING HORMONE (FSH) RESULTS, FOR ONE PATIENT, INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM USED IN CONJUNCTION WITH ACCESS TOTAL SSHCG AND ACCESS HFSH ASSAYS AND CALIBRATORS. SUBSEQUENT ANALYSIS OF THE PATIENT'S SAMPLE, ON AN ALTERNATE ACCESS 2 SYSTEM, RECOVERED HIGHER THCG AND FSH RESULTS WHICH WERE CONSIDERED CORRECT AND ISSUED TO THE HOSPITAL. THE RESULTS FROM THE ORIGINAL INSTRUMENT WERE NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. THE CUSTOMER STATED LEVEL 1 QUALITY CONTROL (QC) WAS OUTSIDE OF SPECIFICATIONS, BUT LEVELS 2 AND 3 WERE WITHIN SPECIFICATIONS. THE CUSTOMER INDICATED THE SERUM SAMPLES WERE CENTRIFUGED AT 3,500 RPM (ROTATIONS PER MINUTE) FOR TEN MINUTES IN A PRESET CENTRIFUGE. SYSTEM CHECK, PERFORMED ON THE DAY OF THE EVENT, PASSED WITHIN SPECIFICATIONS. THE CUSTOMER WAS ADVISED NOT TO OPERATE THE INSTRUMENT UNTIL SERVICE OF THE INSTRUMENT WAS COMPLETE. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113570 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE DHA BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1