BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXL 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2073402 · Received May 1, 2011

    Report

    Report Number
    2122870-2011-01226
    Event Type
    Malfunction
    Date Received
    May 1, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRIOR SYSTEM CHECKS PASSED CUSTOMER SPECIFICATIONS BUT WERE NEAR THE UPPER LIMIT OF ACCEPTANCE CRITERIA FOR A PASSING SYSTEM CHECK. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND ON-SITE (B)(4) 2011. FSE WAS ON-SITE AGAIN (B)(4) 2011 FOR THE SAME ISSUE. FSE MADE MULTIPLE ADJUSTMENTS AND PART REPLACEMENTS TO THE INSTRUMENT TO RESOLVE THE IMPRECISION FOR THE GI 19-9 ASSAY. FSE REPLACED SPIN GRIPPER SET (WHICH SHOWED SIGNS OF CRACKING), CORRECTED MIS-ALIGNMENT OF PIPETTOR #4 (WHICH WAS NOT VERTICALLY STRAIGHT), FASTENED LOOSE BLACK NUT ON PRECISION PUMP, REPLACED SERVICE LOOP TUBING AND REPLACED THE CERAMIC ROTOR AND STATOR. AFTER SERVICE INTERVENTION, GI 19-9 PERFORMANCE IMPROVED TO ACCEPTABLE PRECISION SPECIFICATIONS BUT NO CLEAR HARDWARE ROOT CAUSE WAS DETERMINED. FSE VERIFIED SYSTEM PERFORMANCE TO PUBLISHED SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THEIR LABORATORY HAD HIGH %CV RESULTS ON THEIR PRECISION RUNS OF THE GI MONITOR 19-9 ASSAY. NO ERRONEOUS RESULTS WERE GENERATED AND THERE WAS NO AFFECT TO PATIENT REPORTED IN CONNECTION 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