BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXL 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2079401 · Received May 5, 2011

    Report

    Report Number
    2122870-2011-01207
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    March 25, 2011
    Report Date
    April 7, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE COLLECTION OR CENTRIFUGATION DATE WAS SUPPLIED. NO QC OR SYSTEM CHECK DATA WAS SUPPLIED. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND NOTICED THE HIGHER GI MONITOR RESULTS WERE OCCURRING ON ONE REAGENT PIPETTOR. FSE VERIFIED ULTRASONICS,ALIGNMENTS AND CHANGED THE PISTON AND BELT ON PRECISION PUMP AND ALSO REPLACED THE TRANSDUCERS ON 2 REAGENT PIPETTORS DUE TO DIFFICULTY ADJUSTING THE ULTRASONICS. ALL VERIFICATION TESTING MET SPECIFICATIONS. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED, A CLEAR ROOT CAUSE FOR THIS EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING A HIGHER THAN EXPECTED GI MONITOR RESULT FOR ONE PATIENT'S SAMPLE GENERATED BY THE UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM. UPON REPEAT, THE RESULT WAS IN A LOWER CLINICAL RANGE. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1