BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI® 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 3191902 · Received June 27, 2013

    Report

    Report Number
    2122870-2013-00575
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 30, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    DHA
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED ON (B)(4) 2013 AND PROACTIVELY REPLACED THE ASPIRATE PROBE TUBING WITHOUT COMPLETING ANY OTHER REPAIRS. THE FSE DID NOT PROVIDE EVIDENCE TO REASONABLY CONCLUDE THE ASPIRATE PROBE TUBING HAD MALFUNCTIONED. A SIMILAR EVENT RECURRED ON (B)(6) 2013 AND AN FSE WAS DISPATCHED AGAIN. PLEASE SEE MEDWATCH REPORT # 2122870-2013-00576 FOR AN ASSOCIATED REPORT OF THE EVENT WHICH OCCURRED ON (B)(6) 2013. THE FSE REPORTED THAT THE SAMPLE PIPETTOR FAILED CARRYOVER TESTING AND THE FSE PROCEEDED TO REPLACE THE PIPETTE TIP. THE FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES AND OBTAINED PASSING CARRYOVER TESTING AND BHCG PRECISION TESTS WITH QC MATERIAL. RESULTS: FAILURE MODE IS ATTRIBUTED TO THE SAMPLE PIPETTE TIP AND REPLACEMENT OF THE TIP RESOLVED THE ISSUE. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS EVENT: 2122870-2013-00575 2122870-2013-00576.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING NON-REPRODUCIBLE, ELEVATED ACCESS HCG (BETA-HUMAN CHORIONIC GONADOTROPIN) PATIENT RESULTS, FOR TWO (2) PATIENTS, INVOLVING THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER INDICATED THAT REPEAT TESTING OF THE FIRST PATIENT SAMPLE PRODUCED LOWER RESULTS WITHIN THE NORMAL RANGE OF THE ASSAY, ON BOTH THE ORIGINAL INSTRUMENT AND ON THE ALTENATE DXI 800 ANALYZER. REPEAT TESTING OF THE SECOND SAMPLE PRODUCED A HIGHER RESULT ON THE ORIGINAL INSTRUMENT BUT A LOWER RESULT ON THE ALTERNATE DXI 800 ANALYZER. THE PATIENT RESULTS WERE NOT REPORTED OUT OF THE LABORATORY AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER INDICATED THAT SYSTEM CHECKS WERE PASSING PRIOR TO THE EVENT AND QC (QUALITY CONTROL) WAS RECOVERING WITHIN THE CUSTOMER'S ESTABLISHED RANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294804 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