BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2416324 · Received January 13, 2012

    Report

    Report Number
    2122870-2012-00098
    Event Type
    Malfunction
    Date Received
    January 13, 2012
    Date of Event
    December 12, 2011
    Report Date
    December 14, 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
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT SAMPLES WERE COLLECTED IN 13X100MM SERUM SAMPLE TUBES WITH A GEL BARRIER AND CENTRIFUGED FOR 10 MINUTES AT 3000RPM. QC AND SYSTEM CHECK INFORMATION HAVE NOT BEEN SUPPLIED TO DATE. PER THE CUSTOMER INVESTIGATION RECORD, THE ERRONEOUS ELEVATED AND IMPRECISE PATIENT RESULTS WERE ALL GENERATED ON INSTRUMENT PIPETTOR #2. THE BEC FIELD SERVICE ENGINEER (FSE) AND PERFORMED ALIGNMENTS ON PIPETTOR #2 AND THE ISSUE WAS RESOLVED. THE FSE VERIFIED INSTRUMENT HARDWARE AFTER SERVICING THE INSTRUMENT. ALTHOUGH THE FSE COMPLETED SOME REQUIRED SERVICE TO PIPETTOR #2, IT COULD NOT BE DETERMINED THAT THIS WAS THE ROOT CAUSE OF THE ERRONEOUS PATIENT RESULTS. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. THIS REPORT IS RELATED TO THE FOLLOWING MDRS THAT ARE BEING REPORTED ON DIFFERENT DATES FOR THE SIMILAR EVENT THAT OCCURRED AT THIS CUSTOMER SITE: 2122870-2012-00099, 2122870-2012-00100, 2122870-2012-00101, 2122870-2012-00102, 2122870-2012-00103, 2122870-2012-00104.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) IN REGARDS TO OBTAINING GI MONITOR PATIENT RESULTS WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY FOR TWO (2) PATIENTS THAT THE CUSTOMER CONSIDERED TO BE ERRONEOUS, THAT WERE GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. REPEAT TESTING OF THE PATIENT SAMPLES PRODUCED LOWER RESULTS, STILL WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY BUT OUTSIDE OF LABELED GI MONITOR PRECISION CLAIMS. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY; HOWEVER, 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 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER INC. DXI 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1