BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2414446 · Received January 13, 2012

    Report

    Report Number
    2122870-2012-00070
    Event Type
    Malfunction
    Date Received
    January 13, 2012
    Date of Event
    November 28, 2011
    Report Date
    December 14, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LGD
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION HAS NOT BEEN SUPPLIED TO DATE. TOXO IGM QC HAS BEEN PERFORMING WITHIN THE ESTABLISHED RANGE. SPECIFIC QC DATA HAS NOT BEEN SUPPLIED TO DATE. ADDITIONAL SYSTEM INFORMATION, SUCH AS SYSTEM CHECK AND MAINTENANCE LOGS, HAS NOT BEEN SUPPLIED TO DATE. THE CUSTOMER SENT THE SAMPLE TO BECKMAN COULTER FOR ADDITIONAL TESTING. TESTING OF THE PATIENT SAMPLE BY BECKMAN COULTER CUSTOMER PRODUCT LINE SUPPORT (CPLS) PRODUCED A NON-REACTIVE RESULT FOR TOXO IGM. NO ROOT CAUSE WAS DETERMINED. HOWEVER, AS NO INSTRUMENT PERFORMANCE ISSUES WERE NOTED, AN ISSUE IN PRE-ANALYTICAL STEP MAY BE THE ROOT CAUSE OF THIS PHENOMENON. BECKMAN COULTER RECOMMENDS TO FOLLOW SAMPLE TUBE MANUFACTURER'S INSTRUCTIONS IN TERM OF CLOTTING TIME, TUBE MIXING (NUMBER OF INVERSIONS WHEN MIXING BLOOD), SPEED AND G FORCE WHEN SPINNING. BECKMAN COULTER WOULD RECOMMEND TO CUSTOMER, IN CASE OF SIMILAR ISSUE, TO TRANSFER THE SAMPLE FROM THE ORIGINAL TUBE AND RE-CENTRIFUGED PRIOR TO RE-TEST. IF RESULT REMAINS THE SAME, CUSTOMER SHOULD SEND SAMPLE TO BECKMAN COULTER CPLS FOR INVESTIGATION AS WELL AS ARCHIVE DATA FILE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER THAT UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM GENERATED REPRODUCIBLE REACTIVE TOXOPLASMA IGM (ACCESS TOXO IGM II) RESULTS FOR ONE PATIENT. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING ON TWO ALTERNATE METHODOLOGIES PRODUCED LOWER, DISCORDANT NEGATIVE RESULTS. THE PATIENT'S TOXOPLASMA IGG RESULTS WERE REPRODUCIBLY NON-REACTIVE. THE PATIENT RESULTS ARE SHOWN. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT. SIMILAR EVENT AT THE CUSTOMER SITE ON A SUBSEQUENT DRAW FROM THE SAME PATIENT IS DOCUMENTED IN MDR #2122870-2011-00071. ACCESS TOXO IGM II REAGENT 2X50 TESTS: CATALOGUE NUMBER 34470, LOT NUMBER 191280, PRODUCT CODE LGD, TOXOPLASMA IMMUNOGLOBULIN KIT, 510(K) NUMBER K002453.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1