BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 3081742 · Received April 29, 2013

    Report

    Report Number
    2050012-2013-00289
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER CTS (CUSTOMER TECHNICAL SUPPORT) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING OVER THE PHONE AND THE CUSTOMER STATED THAT THE PROBE MADE UNUSUAL NOISE AS IT ASPIRATED SAMPLES. THE CTS ADVISED THE CUSTOMER TO REPLACE THE CARTRIDGE CHEMISTRY SAMPLE PROBE. THE CUSTOMER ALSO INDICATED THAT THE WASH COLLAR HAD A CLOT AND THE CUSTOMER DID NOT HAVE A REPLACEMENT WASH COLLAR. THE CUSTOMER WAS UNABLE TO RID THE CLOT FROM THE WASH COLLAR AND A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED TO ASSESS THE INSTRUMENT. THE FSE DETERMINED THAT THE CLOGGED WASH COLLAR WAS DUE TO A FAILURE OF THE CAP PIERCER AUTOGLOSS TUBING. THE FSE REPLACED THE CAP PIERCER AUTOGLOSS TUBING AND THE WASH COLLAR TO RESOLVE THE ISSUE. FAILURE MODE IS ATTRIBUTED TO THE CAP PIERCER AUTOGLOSS TUBING. THIS REPORT REFERENCES THE EVENT WHICH OCCURRED ON (B)(6) 2013. PLEASE REFER TO MEDWATCH #2050012-2013-00290 FOR AN ASSOCIATED REPORT RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY LOW CK (CREATININE KINASE) AND TBIL (TOTAL BILIRUBIN) RESULTS FOR MULTIPLE PATIENTS, OVER SEPARATE DAYS, INVOLVING THE UNICEL DXC 800 SYNCHRON SYSTEM. THE CUSTOMER PROVIDED DATA FOR THREE PATIENT SAMPLES BUT THE RESULTS FOR ONE PATIENT SAMPLE WERE WITHIN THE ASSAY'S PRECISION CLAIM. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. QC (QUALITY CONTROL) RESULTS WERE WITHIN THE LABORATORY'S ESTABLISHED RANGES BEFORE AND AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185765 UNICEL® DXC 800 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1