BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1033189 · Received April 23, 2008

    Report

    Report Number
    2122870-2008-00133
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    April 9, 2008
    Report Date
    April 23, 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
    TX, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN SPECIFICATIONS BEFORE AND AFTER THE EVENT. QC DATA WAS COMPARABLE TO THE CUSTOMER'S PEERS. A SYSTEM CHECK PERFORMED IN 2008 WAS WITHIN SPECIFICATIONS. ANOTHER SYSTEM CHECK PERFORMED ON SIX DAYS LATER CONTAINED SOME PARAMETERS ELEVATED, BUT WAS STILL WITHIN THE SPECIFICATIONS. THE SYSTEM CHECK WAS REPEATED ON THE SAME DAY WITH GOOD RESULTS. BASED ON ARCHIVE DATA, THE ELEVATED AND THE LOWER PT RESULTS WERE OBTAINED FROM THE SAME REAGENT PACK, NEAR THE END OF THE PACK. THE SPECIMENS WERE COLLECTED INTO 13 X 100 LITHIUM HEPARIN PLASMA GEL TUBES AND WERE CENTRIFUGED AT 3,700 RPM FOR 10 MINUTES AT ROOM TEMPERATURE. PER CUSTOMER, THE SAMPLES WERE NOT SHORT DRAWS AND VISUALLY APPEARED "OK". PRIOR TO TESTING, THE SAMPLES WERE ALIQUOTED INTO 3ML SAMPLE CONTAINERS. NO ERRORS WERE POSTED TO THE EVENT LOG AT THE TIME OF THIS EVENT. A FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED TO THE CUSTOMER'S LAB AS CUSTOMER DECLINED SERVICE. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ELEVATED TROPONIN (ACCU TNI) RESULTS GENERATED BY THE ACCESS 2 INSTRUMENT FOR TWO PTS. PTA: A SAMPLE FROM THIS PT GAVE A RESULT OF 4.61 NG/ML. THE SAMPLE WAS RETESTED THREE TIMES AND REPEATED RESULTS WERE: 1.44NG/ML, 0.67NG/ML, AND 0.07NG/ML RESPECTIVELY. PT B: AN INITIAL ACCU TNI RESULT WAS 2.40NG/ML. THE ORIGINAL SAMPLE WAS RETESTED THREE TIMES AND REPEATED RESULTS WERE: 6.55NG/ML, 0.13NG/ML, AND 0.02NG/ML RESPECTIVELY. AN ELEVATED RESULT FOR ONE OF THE TWO PTS WAS REPORTED OUT OF THE LAB. THE CUSTOMER HAS NOT RECEIVED ANY REPORT OF DEATH, INJURY, OR CHANGE TO PT TREATMENT AS A RESULT OF 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 IMMUNOASSAY SYSTEM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA