BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS

    MDR report key: 935433 · Received October 30, 2007

    Report

    Report Number
    2050012-2007-00037
    Event Type
    Other
    Date Received
    October 30, 2007
    Date of Event
    October 10, 2007
    Report Date
    October 30, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN WAS COLLECTED IN A GOLD TOP SERUM SEPARATOR TUBE. UPON VISUAL INSPECTION, THE SAMPLE WAS CLEAR WITH NO EVIDENCE OF CLOTS. QC PERFORMED PRIOR TO THE EVENT AND FOLLOWING THE EVENT WAS ACCEPTABLE. THERE WERE NO INSTRUMENT ERROR FLAGS OR MESSAGES AT THE TIME OF THIS EVENT. AFTER THE EVENT, AN OPERATOR CALIBRATED GLUM, RAN QC, AND THEN REPEATED ALL SAMPLES FOR GLUM SINCE THE PREVIOUS ACCEPTABLE QC RUN. NO OTHER DISCREPANT GLUM RESULTS WERE SEEN. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB IN 2007: A) THE FSE INSPECTED THE INSTRUMENT FOR EVIDENCE OF LEAKS, BUT DID NOT FIND ANY. B) THE FSE VERIFIED THAT THE GLU MODULE WAS WORKING WITHIN SPECIFICATIONS. C) THE FSE REPLACED A WASH COLLAR ON THE MODULAR CHEMISTRY (MC) SAMPLE PROBE DUE TO AN EVIDENCE OF A CLOT BEING DRAWN INTO THE COLLAR. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING AN ERRONEOUSLY LOW GLUCOSE (GLUM) RESULT THAT WAS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS FOR A SINGLE PATIENT SAMPLE. A PATIENT SAMPLE WAS TESTED FOR GLUM AND A RESULT OF 137MG/DL WAS OBTAINED. THE RESULT WAS REPORTED OUT OF THE LAB AND QUESTIONED BY THE MEDICAL STAFF BECAUSE IT DID NOT MATCH THE POC GLU RESULT OF "400+MG/DL". THE ORIGINAL SAMPLE WAS RE-TESTED FOR GLUM AND THE REPEATED RESULT WAS 400MG/DL. BASED ON AVAILABLE INFORMATION, PATIENT TREATMENT WAS NOT INITIATED OR WITHHELD BASED ON THE ERRONEOUSLY LOW GLUM RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR Other