BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 3233105 · Received July 18, 2013

    Report

    Report Number
    2050012-2013-00493
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 25, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONTROLS WERE RUN BEFORE AND AFTER THIS INCIDENT AND THE RESULTS WERE WITHIN THE ESTABLISHED RANGES. THE PATIENT SAMPLE WAS COLLECTED IN A LI HEPARIN PLASMA SEPARATOR TUBE AND WAS DECAPPED FROM THE PRIMARY TUBE IN THE AUTOMATION LINE. THE SAMPLE WAS STORED AT ROOM TEMPERATURE. BEC HOTLINE CONFIRMED THAT MAINTENANCE ON THE INSTRUMENT WAS UP TO DATE. HOTLINE OFFERED TO SEND SERVICE BUT THE CUSTOMER REFUSED. THE CUSTOMER STATED THAT THEIR FIELD SERVICE ENGINEER (FSE) HAS COMPLETED THE PREVENTIVE MAINTENANCE (PM) ON THIS INSTRUMENT THE PREVIOUS WEEK. THE CUSTOMER BELIEVED THIS WAS AN ISOLATED INCIDENT. FAILURE MODE IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING THAT THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER GENERATED ONE (1) FALSE LOW CREATININE MODULAR CHEMISTRY (CREM) PATIENT RESULT. THE FALSE LOW CREM PATIENT RESULT WAS REPORTED OUT OF THE LABORATORY AND WAS QUESTIONED BY THE PHYSICIAN. THE ORIGINAL RESULT WAS NOT QUESTIONED BY THE LAB TECHNICIAN BECAUSE THERE WAS NO PREVIOUS CREATININE RESULT TO COMPARE FOR DELTA CHECK. THE ORIGINAL FALSE CREM RESULT YIELDED A VALUE OF 0.7 MG/DL. THE PHYSICIAN INDICATED THAT THE PATIENT HAS A HISTORY OF CREM RESULTS OF OVER 2.0 MG/DL. A NEW SAMPLE WAS SENT TO THE LABORATORY FOR RETEST AND A RESULT OF 2.4 MG/DL WAS OBTAINED. THE CUSTOMER ALSO RERAN THE ORIGINAL SAMPLE AND GOT A HIGHER RESULT OF 2.6 MG/DL. NO OTHER CHEMISTRIES WERE AFFECTED. THE CUSTOMER ALSO RERAN PREVIOUSLY RUN PATIENT SAMPLES FOR CREM AND FOUND NO DISCREPANCY. THERE WERE NO REPORTS OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336057 UNICEL® DXC 800 PRO SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR