BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 812386 · Received January 8, 2007

    Report

    Report Number
    2122870-2007-00006
    Event Type
    Other
    Date Received
    January 8, 2007
    Date of Event
    December 14, 2006
    Report Date
    January 8, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN SPECIFICATION PRIOR TO AND AFTER THE EVENT. SYSTEM CHECK PERFORMED ON 12/08/2006 PASSED. THE SPECIMEN WAS COLLECTED IN A BD, 13X100, SERUM TUBE WITHOUT GEL SEPARATORS AND CENTRIFUGED AT 1,300 RCF FOR 10 MINS AT AMBIENT TEMPERATURE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB. THE FSE PERFORMED PRECISION TESTING AND FIELD DIAGNOSTICS TESTING; BOTH PASSED WITHIN SPECIFICATIONS. THE FSE VERIFIED INSTRUMENT PERFORMANCE PER ESTABLISHED PROCEDURES. PRE-ANALYTICAL FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT. HOWEVER, A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING AN ERRONEOUSLY HIGH DIGOXIN RESULT FROM A SINGLE PT SAMPLE THAT WAS GENERATED BY THE UNICEL DXL 800 ACCESS INSTRUMENT. A PT SAMPLE WAS TESTED FOR DIGOXIN AND A RESULT OF 2.14NG/ML WAS OBTAINED. THE CUSTOMER'S CRITICAL LEVEL FOR DIGOXIN IS SET AT 2.0 AND THE SAMPLE WAS REPEATED VIA REFLEX AND PRODUCED A RESULT OF 2.57NG/ML. THE ORIGINAL SAMPLE WAS RE-CENTRIFUGED AND POURED OFF FOR RETESTING; THE REPEATED RESULT WAS 1.91NG/ML. THE CUSTOMER RE-TESTED THE ORIGINAL SAMPLE ONCE MORE AND DIGOXIN RESULT OF 1.78NG/ML WAS REPORTED OUT OF THE LAB. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PT TREATMENT THAT CAN BE ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA