BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2502663 · Received March 23, 2012

    Report

    Report Number
    2122870-2012-00853
    Event Type
    Malfunction
    Date Received
    March 23, 2012
    Date of Event
    February 18, 2012
    Report Date
    February 27, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JLW
    PMA / PMN Number
    K023764
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INDICATION THAT A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT TO DATE. THE SAMPLES WERE SENT TO CUSTOMER PRODUCT LINE SUPPORT (CPLS) FOR ADDITIONAL TESTING; UNFORTUNATELY SAMPLE INTEGRITY WAS COMPROMISED DURING TRANSIT; HENCE NO TESTING WAS PERFORMED. A DEFINITIVE ROOT CAUSE FOR THIS EVENT CAN NOT BE DETERMINED SINCE BEC WAS UNABLE TO CONDUCT FURTHER INVESTIGATION ON THE SAMPLE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT SAMPLE WAS RUN ON THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM AND ELEVATED TSH RESULT WAS OBTAINED, THAT WAS CONCLUDED TO BE CORRECT AND WAS REPORTED OUT OF THE LABORATORY. BASED ON THE REPORTED RESULT, THE PHYSICIAN ADJUSTED THE PATIENT'S SYNTHROID MEDICATION DUE TO THE ELEVATED RESULTS FROM 75 UG/DAY TO 100 UG/DAY. THIS EVENT IS DOCUMENTED IN MDR 2122870-2012-00771 ON (B)(6) 2012, A CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) IN REGARDS TO OBTAINING ELEVATED TSH RESULT (>100 MU/ML) FOR THE PATIENT RESULT WHICH WAS RUN ON (B)(6) 2012. THE SAMPLE WAS REPEATED ON THE SAME UNIT AND >100 MU/ML WAS OBTAINED. 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. THIS RESULT WAS QUESTIONED BY THE PHYSICIAN SINCE IT DID NOT MATCH THE PATIENT'S CLINICAL PICTURE AND THE PREVIOUS TSH RESULT WHICH WAS RUN ON (B)(6) 2011. THE PATIENT SAMPLE WAS SENT OUT AND RUN ON AN ALTERNATE LABORATORY METHODOLOGY ON TWO DIFFERENT DAYS ((B)(6) 2012) AND LOWER RESULTS (0.09 AND 0.07 MIU/ML) WERE OBTAINED. THE CUSTOMER REPEATED THE SAMPLE USING SCANTIBODY TUBE AND ADDITIONAL LOWER RESULTS OF 0.68 AND 0.66 WAS OBTAINED. ON (B)(6) 2012 THE CUSTOMER REPEATED THE PATIENT SAMPLE RUN FROM (B)(6) 2012 AND 99.55 MU/ML WAS OBTAINED. THE PATIENT'S FREE T3 (3.96 PG/ML)), FREE T4 (19.3NG/DL) AND TOTAL T3 (1.63NG/ML) RESULTS WERE WITHIN THE LABORATORY'S NORMAL REFERENCE RANGES. THE SAMPLE WAS COLLECTED IN BD SST 13 X 100 MM VACUTAINER AND STORED IN THE REFRIGERATOR PRIOR TO USE. THE SAMPLE WAS USED WITHIN 1 DAY OF COLLECTION AND WAS CENTRIFUGED AT 3000 RPM FOR 10 MINUTES AT ROOM TEMPERATURE. CONTROLS WERE RUN PRIOR TO THE EVENT. QC DATA WAS NOT PROVIDED. THE UNIT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS AND REPRODUCIBILITY. THIS MDR COVERS THE EVENT FROM (B)(6) 2012. THE TWO OTHER EVENTS ARE COVERED UNDER MDR 2122870-2012-00771 AND 2122870-2012-00852.

    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 JLW BECKMAN COULTER INC. DXI 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR