BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 1022621 · Received March 31, 2008

    Report

    Report Number
    2122870-2008-00097
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 31, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN SPECIFICATIONS. HOWEVER, ACTUAL QC DATA WAS NOT PROVIDED. THE SPECIMEN WAS HEPARINIZED PLASMA. NO ADDITIONAL PRE-ANALYTICAL SAMPLE HANDLING INFORMATION WAS SUPPLIED. A FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED FOR THIS EVENT. IN A FOLLOW-UP WITH THE CUSTOMER REGARDING THIS EVENT IN 2008, THEY DID NOT REPORT ANY FURTHER ISSUES. NO ADDITIONAL INFORMATION REGARDING THIS EVENT IS AVAILABLE. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. 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 TROPONIN (ACCU TNI) RESULT GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR A SINGLE PATIENT SAMPLE. THE INITIAL ACCU TNI RESULT WAS 0.01NG/ML AND THE CUSTOMER'S DATA LINK 2000 (DL2000) CREATED A DELTA CHECK DUE TO THE PATIENT'S 40NG/ML ACCU TNI RESULT FROM THE PREVIOUS DAY. THE SAMPLE WAS RETESTED FOR ACCU TNI AND A RESULT OF 18.51NG/ML WAS OBTAINED. THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LAB. THE CUSTOMER DID NOT REPORT PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA