BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 762891 · Received August 29, 2005

    Report

    Report Number
    2122870-2005-00129
    Event Type
    Other
    Date Received
    August 29, 2005
    Date of Event
    August 9, 2005
    Report Date
    August 29, 2005
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE CUSTOMER INDICATED THAT QC WAS IN THE RANGE BEFORE THE EVENT. THE CUSTOMER INDICATED THAT TWO (2) OF THREE (3) QC LEVELS WERE WITHIN THE RANGE AFTER THE EVENT. THE CUSTOMER RUNS QC DAILY. SYSTEM CHECK PERFORMED ON 08/09/05 (EXACT TIME NOT PROVIDED, BUT BELIEVED TO BE AFTER THE EVENT) FAILED; RESULTS WERE NOT SUPPLIED. THE SAMPLE WAS COLLECTED IN A PLASTIC BECTON DICKINSON (BD) LITHIUM HEPARIN TUBE WITH GEL SEPARATION AND CENTRIFUGED AT 3,500 RPM FOR TEN (10) MINUTES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER LAB. THE FSE INDICATED THAT AN AUDIBLE NOISE WAS HEARD FROM AN INCUBATOR BELT. THE FSE REMOVED AN ANALYTICAL MODULE, INSPECTED, CLEANED AND RE-INSTALLED IT BACK. THE FSE PERFORMED THE INCUBATION BELT CALIBRATION; THE NOISE DISAPPEARED. THE FSE RAN SYSTEM CHECK (WASHED PORTION ONLY); THE RESULTS WERE WITHIN THE SPECIFICATIONS. THE FSE PERFORMED A DIAGNOSTIC TEST AND AN ACCU TNI PRECISION TEST; ALL RESULTS WERE WITHIN THE SPECIFICATIONS. THE PT SAMPLE WAS RE-TESTED AND TREATMENT WAS NOT AFFECTED IN THIS EVENT. ON A RECUR EVENT, ADDITIONAL TESTING MAY NOT HAVE BEEN DONE AND TREATMENT DECISIONS COULD BE AFFECTED. A CLEAR ROOT CAUSE IN THIS EVENT HAS NOT BEEN DETERMINED. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING AN ERRONEOUSLY ELEVATED TROPONIN (ACCU TNI) RESULT FROM A SINGLE PT THAT WAS GENERATED BY THE ACCESS 2 INSTRUMENT. THE CUSTOMER INDICATED THAT THE ELEVATED ACCU TNI RESULT WAS 8.71NG/ML. THE CUSTOMER INDICATED THAT THE ACCU TNI RESULT WAS INCONSISTENT WITH THE PT DIAGNOSIS AND WITH OTHER RESULTS. THE PT SAMPLE WAS RE-TESTED FOR ACCU TNI; THE RESULT WAS 0.01NG/ML. THE CUSTOMER INDICATED THAT THERE WAS NO CHANGE IN PT TREATMENT THAT CAN BE ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA