BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 3020374 · Received March 26, 2013

    Report

    Report Number
    2122870-2013-00311
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    DHA
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER THAT THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM GENERATED A DILUTED HUMAN CHORIONIC GONADOTROPIN (DIL-HCG) RESULT THAT WAS NOT MATCHING THE PATIENT'S TOTAL BETA HUMAN CHORIONIC GONADOTROPIN (TBHCG) RESULT GENERATED BY THE SAME SYSTEM. REPEAT TESTING ON THE SAME INSTRUMENT REPRODUCED THE RESULTS, BUT THE REPEAT TESTING ON AN ALTERNATE INSTRUMENT PRODUCED A DIL-HCG RESULT THAT WAS CONSISTENT WITH THE TBHCG RESULT. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY, AND THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) ADVISED THE CUSTOMER TO LIMIT THE BHCG ASSAY ON THEIR DXI INSTRUMENT TO ONE PIPETTOR. THE CUSTOMER WAS THEN ABLE TO OBTAIN A REPORTABLE DIL-HCG RESULT FROM THE SAMPLE IN QUESTION (APPROX. 1400MIU/ML). THE FSE THEN REPLACED ALL DXI PIPETTOR TIPS AND PERFORMED PIPETTOR ALIGNMENTS TO BE WITHIN SERVICE SPECIFICATION. THE FSE THEN PERFORMED A SYSTEM CHECK, BUT THE RESULTS WERE NOT ACCEPTABLE. THE FSE PERFORMED PIPETTOR MATCHING VERIFICATION TESTING, BUT THE RESULTS WERE QUESTIONABLE. THE FSE THEN REBUILT THE PIPETTOR PRECISION PUMPS AND WAS ABLE TO OBTAIN PASSING PIPETTOR MATCHING RESULTS. AFTER ALL REPAIRS WERE COMPLETED, THE FSE PERFORMED A SYSTEM CHECK AND A HIGH SENSITIVITY SYSTEM CHECK, AND OBTAINED ACCEPTABLE RESULTS. THE FSE DID NOT PROVIDE DEFINITIVE EVIDENCE THAT A SPECIFIC HARDWARE COMPONENT HAD MALFUNCTIONED TO CAUSE THIS EVENT. HOWEVER, THE REPAIRS AND RESOLUTION ACHIEVED BY THE FSE INDICATES THAT HARDWARE MALFUNCTION WAS THE CAUSE OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124287 UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE DHA BECKMAN COULTER DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1