BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2011132 · Received March 8, 2011

    Report

    Report Number
    2122870-2011-00526
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 5, 2011
    Report Date
    February 8, 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

    PER CUSTOMER SUPPLIED DATA, RESULT FOR SAMPLE #1 WAS NOT CORRECTED IN THE LAB INFORMATION SYSTEM (LIS) AFTER REPEAT TESTING. THE SAMPLE WAS COLLECTED IN A LITHIUM HEPARIN TUBE THAT WAS CENTRIFUGED AT 3,500 RPM. THE SPECIMEN WAS NORMAL IN APPEARANCE. QC WAS RECOVERING WITHIN ESTABLISHED RANGES ON AND BEFORE THE DATE OF EVENT. SYSTEM CHECKS PERFORMED ON (B)(6) 2011 PASSED WITH SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) PERFORMED A PREVENTIVE MAINTENANCE (PM). THE FSE PERFORMED A SYSTEM CHECK WHICH PASSED WITHIN SPECIFICATIONS. THE FSE RAN 30 REPS OF TROPONIN USING WASH BUFFER. ALL RESULTS WERE 0.00NG/ML. THE SYSTEM WAS RETURNED TO THE CUSTOMER FOR PATIENT TESTING. NO DEFINITIVE ROOT CAUSE WAS DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING AN ERRONEOUSLY ELEVATED TROPONIN (ACCU TNI) RESULT GENERATED BY THE ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. REPEAT TESTING ON A DIFFERENT METHOD RECOVERED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE. TWO FRESH SAMPLES COLLECTED FROM THE PATIENT ON THE NEXT DAYS AND TESTED ON THE ACCESS ANALYZER ALSO GAVE RESULTS WITHIN THE NORMAL REFERENCE RANGE. THE RESULT WAS REPORTED OUT OF THE LAB. THE CUSTOMER DID NOT REPORT EFFECT TO THE PATIENT OR USER 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 45 YR