BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2484334 · Received March 8, 2012

    Report

    Report Number
    2122870-2012-00631
    Event Type
    Malfunction
    Date Received
    March 8, 2012
    Date of Event
    February 8, 2012
    Report Date
    February 8, 2012
    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
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GI MONITOR SAMPLES WERE COLLECTED IN 7ML, 13X100MM BD SERUM TUBES WITH A GEL SEPARATOR AND CENTRIFUGED ON THE POWER PROCESSOR FOR 10 MINUTES AT 3500 RPM AT ROOM TEMPERATURE. THE CUSTOMER NOTED THAT THE LEVEL 1 GI MONITOR QC FAILED AND BASED ON THE REVIEW OF THE CUSTOMER SUPPLIED DATA CONFIRMED THAT THE LEVEL 1 QC FAILED OUT OF RANGE HIGH MULTIPLE TIMES. IN ADDITION, THE ARCHIVE DATA PROVIDED BY THE CUSTOMER ALSO INDICATES THAT A PRECISION RUN WAS PERFORMED USING WASH BUFFER WHERE ELEVATED RESULTS WERE OBTAINED THAT SHOW HIGH RLUS. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT; HOWEVER, THE DETAILS OF THE SERVICE VISIT HAVE NO BEEN PROVIDED TO DATE. THE CONCLUSION IS STILL PENDING FOR THIS EVENT. ROOT CAUSE IS UNKNOWN TO DATE. THIS REPORT IS RELATED TO THE FOLLOWING MDRS THAT ARE BEING REPORTED ON DIFFERENT DATES AND ON DIFFERENT INSTRUMENTS FOR THE SIMILAR EVENT THAT OCCURRED AT THIS CUSTOMER SITE: DXI 800 SERIAL # (B)(4) (SAME INSTRUMENT DOCUMENTED IN THIS REPORT) - 2122870-2012-00630, 2122870-2012-00632, 2122870-2012-00633. DXI 800 SERIAL # (B)(4) - 2122870-2012-00634. DXI 800 SERIAL # (B)(4) - 2122870-2012-00635.

    Additional Manufacturer Narrative · 1

    FOLLOWING FURTHER INVESTIGATION, THE CUSTOMER STATED THE CAUSE OF THE EVENT WAS CONTAMINATION OF THE TOP OF THE REAGENT PACKS. AFTER WEARING GLOVES AND NOT TOUCHING THE TOP OF THE REAGENT PACKS, NO FURTHER DISCREPANT RESULTS WERE NOTED. THE CUSTOMER NOTED ALIGNMENT OF THE PIPETTORS ALSO IMPROVED OVERALL REPRODUCIBILITY RESULTS. THE CUSTOMER RETRAINED THE LABORATORY STAFF ON REAGENT PACK AND SAMPLE HANDLING AND STATED THE ISSUE HAS BEEN RESOLVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) IN REGARDS TO OBTAINING ERRATIC GI MONITOR RESULTS FOR SEVERAL PATIENTS GENERATED ON THREE DIFFERENT UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEMS (SERIAL #S (B)(4)), USED IN CONJUNCTION WITH ACCESS GI MONITOR REAGENT (LOT # 117293) AND ACCESS GI MONITOR CALIBRATORS (LOT # 112491). THIS EVENT OCCURRED OVER THE COURSE OF SEVERAL DAYS, RANGING FROM (B)(6) 2012. THIS REPORT DOCUMENTS THE RESULTS OBTAINED ON (B)(6) 2012 AND ON THE DXI 800 INSTRUMENT SERIAL # (B)(4). THE CUSTOMER HAS ALSO OBTAINED FAILING GI MONITOR QC AND PRECISION TEST RESULTS. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY; HOWEVER, THERE WAS NO DEATH OR INJURY ASSOCIATED WITH THIS EVENT AND PATIENT TREATMENT WAS NOT IMPACTED. THE RESULTS PROVIDED BY THE CUSTOMER ARE SHOWN IN THE ATTACHMENT SECTION OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER INC. DXI 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1