BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL ¿ DXI 800 ACCESS ® IMMUNOASSAY SYSTEM

    MDR report key: 2183469 · Received July 29, 2011

    Report

    Report Number
    2122870-2011-02581
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 28, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JLB
    PMA / PMN Number
    K023764
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT SAMPLE WAS COLLECTED IN A SERUM SEPARATOR TUBE. THE PATIENT SAMPLE WAS CENTRIFUGED ON THE TRACK SYSTEM OF THEIR AUTOMATION LINE. THE SAMPLE WAS RE-CENTRIFUGED PRIOR TO REPEAT TESTING BEING PERFORMED. QC WAS PERFORMING WITHIN THE CUSTOMER'S ESTABLISHED RANGES AT THE TIME OF THE EVENT. ON (B)(4) 2011, A BEC FIELD SERVICE ENGINEER (FSE) PERFORMED SYSTEM CHECKS, WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS BOTH BEFORE AND AFTER COMPLETING SOME VERY MINOR HARDWARE REPAIRS. FSE COMPLETED A PASSING SYSTEM CHECK AND A PASSING HIGH SENSITIVITY SYSTEM CHECK WITHIN INSTRUMENT SPECIFICATIONS PRIOR TO PERFORMING ANY REPAIRS. FSE CLEANED THE ASPIRATE PROBE AND SUBSTRATE PROBE EXTERIORS. FSE TIGHTENED THE DUCK BILL HOUSING NUT. FSE PERFORMED ANOTHER SYSTEM CHECK WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS AND A 12 REPLICATE CK-MB PRECISION RUN ON EACH PIPETTOR AND THE RESULT MET THE ASSAY PRECISION CLAIMS. ALTHOUGH THE FSE DID MAKE SOME MINOR REPAIRS TO INSTRUMENT HARDWARE, A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT TO DATE.

    Additional Manufacturer Narrative · 1

    CHANGE FROM: (B)(6) TO: (B)(6). ADD THE STATE OF (B)(6).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) IN REGARDS TO AN ERRONEOUS ELEVATED CK-MB RESULT ABOVE THE NORMAL REFERENCE RANGE FOR ONE PATIENT GENERATED BY THE UNICEL DXI800 ACCESS IMMUNOASSAY ANALYZER. THE RESULT WAS REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN AND THE PATIENT WAS REDRAWN. THE INITIAL SAMPLE AND THE REDRAWN SAMPLE WERE TESTED ON THE SAME INSTRUMENT AND LOWER RESULTS WITHIN THE RISK STRATIFICATION RANGE OF THE ASSAY WERE OBTAINED. 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 JLB BECKMAN COULTER INC. DXI 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1