BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2120717 · Received June 10, 2011

    Report

    Report Number
    2122870-2011-01789
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE COLLECTED IN A LIHEP GEL SERUM TUBE AND WERE CENTRIFUGED FOR 5 MINUTES AT 3500 RPM. PER THE CUSTOMER, QC WAS PERFORMING WITHIN THE CUSTOMER'S ESTABLISHED RANGES AT THE TIME OF THE EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 AND REPLACED THE PERI-PUMP TUBING DUE TO WHAT WAS NOTED TO HAVE "FLAT SPOTS" AND WEAR. THE FSE CLEANED THE ASPIRATE PROBES AND RAN A SPECIAL CLEAN ON THE INSTRUMENT. THE FSE ALSO COMPLETED A PASSING SYSTEM CHECK WITHIN INSTRUMENT SPECIFICATIONS. ALTHOUGH THE FSE ADDRESSED SEVERAL HARDWARE ISSUES AT THE TIME OF SERVICE, A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING AN ERRONEOUSLY ELEVATED CREATININE KINASE - MB (CKMB) RESULT ABOVE THE NORMAL REFERENCE RANGE FOR ONE (1) PATIENT THAT WAS GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY; HOWEVER, REPEAT TESTING OF THE PATIENT SAMPLE ON THE SAME INSTRUMENT PRODUCED A RESULT IN 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 JJE BECKMAN COULTER INC. DXI 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR