BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2134460 · Received June 20, 2011

    Report

    Report Number
    2122870-2011-01952
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 20, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS LITHIUM HEPARIN PLASMA THAT WAS CENTRIFUGED AT 3,600RPM FOR 10 MINUTES. CUSTOMER OBSERVED A DROP OF FLUID ON TOP OF REAGENT PACKS AND FLUID HANGING FROM THE TIP OF REAGENT PIPETTOR #4., AND THEY DISABLED REAGENT PIPETTOR #4, AND REPEATED ALL SAMPLES ANALYZED ON THE NIGHT SHIFT. ON (B)(6) 2011 ONE LEVEL QC WAS PERFORMED ON (B)(6) 2011 PRIOR TO THE EVENT AND WAS WITHIN SPECIFICATIONS. THIS QC DID NOT USE REAGENT PIPETTOR #4. ALL LEVELS OF QC, A TOTAL OF NINE VALUES, WERE PERFORMED AFTER THE EVENT. ONLY ONE OF THOSE RESULTS WAS ON REAGENT PIPETTOR #4. THE RESULTS APPEAR TO BE SLIGHTLY ELEVATED COMPARED TO THE OTHER QC VALUES, HOWEVER THE SYSTEM DID NOT FLAG THOSE VALUES AS OUT OF SPECIFICATIONS A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE REPLACED THE O-RINGS AND TIMING BELT OF THE PRECISION PUMP FOR REGENT PIPETTOR #4. REAGENT PIPETTOR #4 FAILED THE PIPETTOR MATCHING TEST. INSTALLED A NEW PRECISION PUMP AND PERFORMED ALL THE NECESSARY ALIGNMENTS AND TESTING. ALL VERIFICATION TESTING MET SPECIFICATIONS. HARDWARE IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) IN REGARDS TO A TROPONIN (ACCUTNI) RESULT, IN THE RISK STRATIFICATION RANGE THAT EXCEEDED THE ASSAY'S PRECISION CLAIMS, GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT'S SAMPLE. THE RESULT WAS NOT REPORTED OUT OF THE LAB THE ERRONEOUS ELEVATED RESULT WAS OBTAINED FROM THE SAMPLES WHICH WAS ANALYZED ON REAGENT PIPETTOR #4. THE SAMPLE WAS REPEATED ON AN ALTERNATE REAGENT PIPETTOR AND LOWER RESULT WITHIN THE NORMAL RANGE WAS OBTAINED. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXI 800 ACCESS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1