BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2001064 · Received February 24, 2011

    Report

    Report Number
    2122870-2011-00457
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 26, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS DRAWN INTO A LITHIUM HEPARIN TUBE AND CENTRIFUGED AT 2300 G FOR 10 MINUTES. QC LEVELS ONE AND TWO RESULTED WITHIN THE CUSTOMER'S ESTABLISHED RANGES ON THE DAY OF THE EVENT. QC LEVEL THREE INITIALLY RESULTED OUT OF RANGE HIGH AND RESULTED WITHIN RANGE UPON REPEAT ANALYSIS. A SYSTEM CHECK WAS PERFORMED ON (B)(6) 2011, WHICH MET SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 AND PERFORMED A HIGH SENSITIVITY (HS) SYSTEM CHECK AND QC VALIDATION TESTING, WHICH BOTH PASSED WITH NO ISSUES NOTED. THE FSE DID NOT NOTE ANY HARDWARE ISSUES THAT CONTRIBUTED TO THIS EVENT. A ROOT CAUSE WAS NOT DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING AN ERRONEOUSLY LOW TROPONIN (ACCUTNI) RESULT FOR ONE PATIENT, GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. RESULTS WITHIN THE RISK STRATIFICATION RANGE WERE OBTAINED UPON REPEAT ANALYSIS ON AN ALTERNATE INSTRUMENT. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT REPORT AFFECT TO THE PATIENT OR END USER ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. ACCESS® 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR