BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1002927 · Received February 8, 2008

    Report

    Report Number
    2122870-2008-00032
    Event Type
    Other
    Date Received
    February 8, 2008
    Date of Event
    January 14, 2008
    Report Date
    February 8, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    (K)023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER COLLECTS PLASMA SAMPLES IN 7ML PLASTIC BD LITHIUM HEPARIN TUBES WITH GEL. THE CUSTOMER CENTRIFUGES SAMPLES AT 3000 RPM FOR 6 MINUTES AT ROOM TEMPERATURE IN A SWINGING BUCKET CENTRIFUGE. SAMPLES THAT WERE RE-SPUN PRIOR TO REPEAT ANALYSIS WERE CENTRIFUGED AT 3500 RPM FOR 10 MINUTES IN A FIXED ANGLE CENTRIFUGE. SAMPLES WERE SAMPLED FROM THE PRIMARY TUBE FOR INITIAL TESTING AND SAMPLED FROM 0.5ML SAMPLE CUPS FOR REPEAT TESTING AFTER BEING RESPUN. QC WAS WITHIN SPECIFICATIONS PRIOR TO AND AFTER THE EVENT. A SYSTEM CHECK PERFORMED ON THE DAY OF THE EVENT AT 16:28 FAILED, OUT OF SPECIFICATIONS HIGH. THE SYSTEM CHECK WHEN REPEATED AT A LATER TIME ON THE SAME DAY, AFTER SERVICE, MET SPECIFICATIONS. PER THE SUPPLEMENTAL DATA FORM, THERE WERE NO ERRORS ON THE EVENT LOG. AN ACTUAL EVENT LOG WAS NOT PROVIDED. A FIELD SERVICE ENGINEER (FSE) WAS ON-SITE FROM 01/14/2008 TO 01/16/2008: PER FSE, THE INCUBATOR WAS CATCHING ON THE FOAM INSULATION. THE FSE REPLACED THE DAMAGED SUBSTRATE PROBE. THE FSE FOUND EVIDENCE OF SPILLS IN THE WASH WHEEL; AND EVIDENCE OF CLOTS AND OVERFLOW OF SAMPLE IN THE WASH STATION. THE FSE PERFORMED PREVENTIVE MAINTENANCE (PM), RAN SYSTEM CHECK AND QC, WHICH ALL MET SPECIFICATIONS. THE FSE VERIFIED INSTRUMENT PER ESTABLISHED PROCEDURES. HARDWARE ISSUES MAY HAVE CONTRIBUTED TO THIS EVENT. HOWEVER, A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE 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 INC. (BCI) REGARDING ERRONEOUSLY HIGH ACCUTNI RESULTS, GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR SEVEN PTS. CUSTOMER TESTED A SAMPLE FOR ACCUTNI AND OBTAINED A RESULT OF 6.97 NG/ML. UPON REPEAT THIS SAMPLE GAVE RESULTS OF 2.70 NG/ML AND 3.25 NG/ML. THIS SAMPLE WAS TESTED ON A DIFFERENT INSTRUMENT AND GAVE A RESULT OF 0.03 NG/ML. SIX OTHER PT SAMPLES WERE TESTED FOR ACCUTNI AND THE INITIAL RESULTS WERE IN THE RANGE OF 0.42 TO 6.39 NG/ML AND THE REPEAT RESULTS WERE IN THE RANGE OF 0.33-2.23 NG/ML. THE SAMPLES WHEN TESTED ON A DIFFERENT INSTRUMENT GAVE RESULTS IN THE RANGE OF 0.03-0.25NG/ML. ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. BASED ON AVAILABLE INFO, PT ONE WAS SENT TO THE HEART CATHETERIZATION LABORATORY. THE CUSTOMER DID NOT REPORT ANY INJURY OR DEATH ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA