BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2180523 · Received July 27, 2011

    Report

    Report Number
    2122870-2011-02593
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 30, 2011
    Report Date
    June 30, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND SPECIFIC CENTRIFUGATION DATA WAS NOT SUPPLIED. CUSTOMER DID NOT PROVIDE QC OR SYSTEM CHECK DATA. THE CUSTOMER ALSO DID NOT PROVIDE ANY INFORMATION INDICATING INSTRUMENT MALFUNCTION. PER THE COMPLAINT RECORD, THE UNIT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS UPON CONTACT WITH THE CUSTOMER. THE LABORATORY HAS AN ACCUTNI PATIENT SAMPLE REPEAT ANALYSIS PROCEDURE, WHICH INCLUDES RE-SPINNING AND RE-ANALYZING ALL ACCUTNI SAMPLES RECOVERING >0.5 NG/ML AND ARE NOT CONFIRMED BY LABORATORY'S DELTA CHECK LABORATORY INFORMATION SYSTEM (LIS) PROCESS. SERVICE WAS NOT DISPATCHED, AS CUSTOMER IS NOT QUESTIONING INSTRUMENT PERFORMANCE. NO CLEAR ROOT CAUSE HAS BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    BECKMAN COULTER INC., (BEC) 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. ACTUAL PATIENT RESULTS WERE NOT SUPPLIED BY THE CUSTOMER. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. 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 JJE BECKMAN COULTER INC. ACCESS 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1