BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 880I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 1960633 · Received January 13, 2011

    Report

    Report Number
    2122870-2011-00060
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 2, 2010
    Report Date
    December 16, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DHA
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN THE ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. THE CUSTOMER SENT THE SAMPLE TO BCI FOR ADDITIONAL TESTING. BCI CUSTOMER PRODUCT LINE SUPPORT (CPLS) WAS ABLE TO REPRODUCE THE CUSTOMER'S RESULTS ON THE UNDILUTED SAMPLE. DILUTION TESTING BY BCI DETECTED INTERFERENCE AS THE RESULTS WERE NOT LINEAR. (B)(4) TESTING SHOWED THE PRESENCE OF INTERFERING SUBSTANCE SINCE AT LEAST ONE OF THE (B)(4) BLOCKERS USED IN THE TEST LOWERED THE SIGNAL. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THE ROOT CAUSE FOR THE EVENT WAS A PATIENT SOURCE INTERFERENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY ELEVATED (B)(6) RESULTS ABOVE THE NORMAL REFERENCE RANGE GENERATED BY UNICEL DXC 880I SYNCHRON ACCESS CLINICAL SYSTEM FOR ONE PATIENT. THE RESULTS WERE REPRODUCIBLE, BUT DILUTION TESTING PRODUCED NON-LINEAR RESULTS. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING ON AN ALTERNATE METHODOLOGY PRODUCED 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® DXC 880I SYNCHRON® ACCESS® CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER DHA BECKMAN COULTER, INC. DXC 880I NA

    Patients

    Seq Age Sex Outcome Treatment
    1