BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2022873 · Received March 17, 2011

    Report

    Report Number
    2122870-2011-00641
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922826
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES ARE COLLECTED IN LITHIUM HEPARIN PLASMA TUBES AND ARE CENTRIFUGED FOR 10 MINUTES AT 3,500 RPM. QC IS RUNNING PER CUSTOMER'S EXPECTED RANGES. A FIELD SERVICE ENGINEER (FSE) PERFORMED A PREVENTIVE MAINTENANCE (PM) AND REPLACED SOME PARTS. A SYSTEM CHECK PASSED AND ACCUTNI PRECISION WAS GOOD WITH NO FLIERS AFTER THE HARDWARE REPLACEMENTS. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULTS GENERATED BY THE ACCESS IMMUNOASSAY SYSTEM FOR SIX PATIENTS. NEGATIVE RESULTS WERE OBTAINED UPON REPEAT ANALYSIS ON A DIFFERENT INSTRUMENT. TO DATE NO PATIENT RESULTS HAVE BEEN SUPPLIED BY THE CUSTOMER. THE RESULTS HAVE BEEN REPORTED OUT OF THE LAB. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. ACCESS® IMMUNOASSAY SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1