BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2190018 · Received August 4, 2011

    Report

    Report Number
    2122870-2011-02670
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    June 23, 2011
    Report Date
    July 5, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LTJ
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE SERUM AND CENTRIFUGED FOR 10 MINUTES AT 3200 RPM. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES DURING THE EVENT. ON (B)(4) 2011, A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THE EVENT. THE FSE REPLACED THE PERI PUMP TUBING AS A PRECAUTIONARY STEP, VERIFIED REAGENT PIPETTOR ALIGNMENTS AND ADJUSTED THEM AS NEEDED. THE FSE ALSO PERFORMED A CARRYOVER TEST AND HIGH SENSITIVITY SYSTEM CHECK WHICH MET SPECIFICATIONS. A CLEAR ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT OBTAINING A HYBRITECH PROSTATE-SPECIFIC ANTIGEN (HYB-PSA) RESULT ABOVE THE NORMAL REFERENCE RANGE FOR ONE (1) PATIENT. THE RESULT WAS REPORTED OUT OF THE LAB AND WAS QUESTIONED BY THE PHYSICIAN. THE ELEVATED RESULT WAS GENERATED ON A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, USED IN CONJUNCTION WITH ACCESS HYB-PSA REAGENT (LOT 021026) AND ACCESS HYB-PSA CALIBRATOR (LOT 022077). REPEAT TESTING OF THE PATIENT'S SAMPLE ON THE SAME INSTRUMENT GENERATED A RESULT WITHIN THE NORMAL REFERENCE RANGE. THE CUSTOMER DID NOT RECEIVE ANY REPORT 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 DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE LTJ BECKMAN COULTER, INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1