BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 3900875 · Received June 27, 2014

    Report

    Report Number
    2122870-2014-00436
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    DHA
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER (BEC) CUSTOMER TECHNICAL SUPPORT (CTS) ADVISED THE CUSTOMER TO PERFORM A TEST TO ASSESS THE DILUTION PERFORMANCE OF THE INSTRUMENT, WHICH FAILED. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE REPLACED THE PIPETTOR TIP, TUBING, ASPIRATE PROBES, RED AND WHITE FITTING, AS WELL AS ALIGNED THE REAGENT PIPETTOR. ASSOCIATED MDR: 2122870-2014-00437.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED INCONSISTENT BETA HUMAN CHORIONIC GONADOTROPIN RESULTS FOR TWO PATIENT SAMPLES ON TWO DATES ON A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE PATIENT SAMPLES WERE TESTED FOR BOTH TOTAL-BETA HUMAN CHORIONIC GONADOTROPIN (TBHCG) AND DILUTED TOTAL-BETA HUMAN CHORIONIC GONADOTROPIN (DIL-HCG.) THE CUSTOMER STATED THAT THERE MAY HAVE BEEN TWO ADDITIONAL OCCURRENCES OF INCONSISTENT TBHCG AND DIL-HCG RESULTS, BUT DID NOT PROVIDE ANY FURTHER DETAILS. THIS MDR REPORTS THE RESULTS GENERATED ON (B)(6) 2014; ON (B)(6) 2014, THE TBHCG AND DIL-HCG RESULTS FOR ONE PATIENT WERE GREATER THAN AND LESS THAN THE REFERENCE RANGE, RESPECTIVELY, ON AN INITIAL ANALYSIS. THE SAMPLE WAS REANALYZED ON THE SAME INSTRUMENT AND ON AN ACCESS 2 IMMUNOASSAY SYSTEM IN THE LABORATORY; THE ACCESS 2 IMMUNOASSAY SYSTEM RESULT WAS BELIEVED TO BE CORRECT AND REPORTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT PROVIDE ANY INSTRUMENT PRINTOUTS OF SAMPLE RESULTS. THERE WAS NO CHANGE TO PATIENT TREATMENT IN ASSOCIATION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376817 UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE DHA BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1