BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1992269 · Received February 15, 2011

    Report

    Report Number
    2122870-2011-00406
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES ARE COLLECTED INTO LITHIUM HEPARIN GEL SEPARATOR TUBES. NO SPECIFIC EVENT QC DATA WAS SUPPLIED. PER THE CUSTOMER, THE UNIT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS UPON CONTACT WITH THE CUSTOMER. CUSTOMER PROVIDED INFORMATION THAT A PROACTIVE PROCEDURE HAS BEEN IMPLEMENTED TO VERIFY UNEXPECTED RESULTS PRIOR TO REPORTING THE RESULT OUTSIDE THE LABORATORY THEREBY PREVENTING POTENTIAL RISK TO PATIENT SAFETY. THE LABORATORY HAS AN ACCUTNI PATIENT SAMPLE REPEAT PROCEDURE IN WHICH ALL UNEXPECTED PATIENT SAMPLE RESULTS ARE RE-SPUN AND RE-ANALYZED. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. A ROOT CAUSE FOR THIS EVENT WAS NOT DETERMINED.

    Description of Event or Problem · 1

    BECKMAN COULTER INC., (BCI) CONTACTED THIS CUSTOMER VIA THE TROPONIN (ACCUTNI) MARKETING SURVEY PROGRAM (MSP) CUSTOMER CONTACT PROGRAM. THE CUSTOMER INDICATED SOME OCCURRENCES OF NON-REPRODUCIBLE FALSE POSITIVE ACCUTNI PATIENT RESULTS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE EVENTS WILL BE ASSUMED THAT THE FALSE POSITIVE ACCUTNI PATIENTS' RESULTS INITIALLY RECOVERED ABOVE THE AMI CUT-OFF WITH REPEAT RESULTS RECOVERING WITHIN NORMAL REFERENCE RANGE. THE CUSTOMER DID NOT REPORT AFFECT TO THE PATIENT OR 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 MMI BECKMAN COULTER INC. ACCESS 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1