BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2262834 · Received September 25, 2011

    Report

    Report Number
    2122870-2011-04080
    Event Type
    Malfunction
    Date Received
    September 25, 2011
    Date of Event
    August 22, 2011
    Report Date
    August 22, 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
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SAMPLES WERE COLLECTED IN "ORANGE TOP" AND "GREEN TOP" SAMPLE TUBES. ADDITIONAL COLLECTION DEVICE AND SAMPLE CENTRIFUGATION INFORMATION HAVE NOT BEEN PROVIDED. PER THE CUSTOMER FEEDBACK EVENT DESCRIPTION, QUALITY CONTROL (QC) WAS PERFORMING WITHIN THE CUSTOMER'S ESTABLISHED RANGES AT THE TIME OF THE EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THE EVENT. THE FSE CLEANED ALL PROBES, WASH STATIONS AND CHECKED SAMPLE PROBE AND ALL REAGENT PIPETTOR ALIGNMENTS. THE FSE REPLACED ALL ASPIRATE PROBES. THE FSE PERFORMED A CARRYOVER TEST AND RESULTS WERE WITHIN INSTRUMENT SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT OBTAINING ERRONEOUSLY ELEVATED TOTAL BETA HUMAN CHORIONIC GONADOTROPIN (T-HCG) RESULTS ABOVE THE NORMAL REFERENCE RANGE FOR THREE (3) PATIENTS GENERATED BY A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, USED IN CONJUNCTION WITH ACCESS T-HCG REAGENT (LOT 109220) AND CALIBRATOR (LOT 017956). REPEAT TESTING OF THE PATIENTS' SAMPLES PRODUCED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY FOR TWO (2) PATIENTS. FOR THE THIRD PATIENT, THE REPEAT RESULTS WERE ELEVATED BUT WERE NOT WITHIN LABELED T-HCG ASSAY PRECISION CLAIMS. ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE WERE NO REPORTS OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1