BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1346235 · Received December 12, 2008

    Report

    Report Number
    2122870-2008-00411
    Event Type
    Malfunction
    Date Received
    December 12, 2008
    Date of Event
    November 26, 2008
    Report Date
    December 12, 2008
    Manufacturer
    BECKMAN COULTER, INC
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE HANDLING INFO HAS BEEN REQUESTED FROM THE CUSTOMER, BUT HAS NOT BEEN RECEIVED TO DATE. PER CUSTOMER, QC WAS WITHIN SPECIFICATIONS. CUSTOMER INDICATED THAT A SYSTEM CHECK RUN IN (B) (4) 2008 MET SPECIFICATIONS; HOWEVER, NO DATA WAS SUPPLIED. A FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED FOR THIS EVENT. THE LAB HAS BIO MED DEPARTMENT WHO VERIFIED THE INSTRUMENT, AND CUSTOMER INDICATED THAT ASPIRATE PROBES WERE REPLACED AND NO FURTHER ISSUES HAVE BEEN NOTED. PLUGGED OR DIRTY ASPIRATE PROBES COULD CONTRIBUTE TO ELEVATED RESULTS DUE TO INCOMPLETE ASPIRATION DURING THE WASHING PROCESS. HOWEVER, NO CLEAR ROOT CAUSE HAS BEEN DETERMINED FOR HIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT. (B) (4).

    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 2 INSTRUMENT FOR ONE PT. A PT SAMPLE WAS TESTED FOR ACCU TNI AND A RESULT OF 16.0NG/ML WAS OBTAINED. THE RESULT WAS REPORTED OUT OF THE LAB. THE LAB HAS A PRACTICE OF REPEATING ANY HIGH ACCU TNI RESULTS OVER >0.1NG/ML. THE SAMPLE WAS THEN RETESTED ON THIS INSTRUMENT AND RECEIVED A RESULT OF 0.2NG/ML. THE SPECIMEN WAS ALSO TESTED ON A DIFFERENT INSTRUMENT AND A RESULT OF 0.01NG/ML WAS OBTAINED. THERE HAS BEEN NO TREATMENT OR INJURY DUE TO THIS EVENT THAT BCI HAS BEEN MADE AWARE OF.

    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 IMMUNOASSAY SYSTEM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA