BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1001709 · Received February 15, 2008

    Report

    Report Number
    2122870-2008-00041
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    January 24, 2008
    Report Date
    February 15, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN WAS PLASMA WITH LITHIUM HEPARIN, COLLECTED IN A GREINER VACUETTE TUBE. THE TUBE WAS INVERTED AT COLLECTION PER MFR'S RECOMMENDATION. THE SAMPLE WAS CENTRIFUGED AT 3,500 RPM FOR 10 MINS. QC WAS WITHIN SPECIFICATIONS PRIOR TO THE EVENT. THE LOW LEVEL OF QC WAS RUN TWICE FOLLOWING THE VENT AND FAILED WITH EXTREMELY ELEVATED RESULTS. CUSTOMER PERFORMED WEEKLY MAINTENANCE BEFORE THE EVENT IN 2008. SEVERAL ERROR MESSAGES WERE POSTED TO THE EVENT LOG AFTER THE EVENT ON THE SAME DAY; HOWEVER, THE DETAILS HAVE NOT BEEN PROVIDED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB. THE FSE FOUND SYSTEM CHECK FAILING. THE FSE DISCOVERED A BLACK SALTY SUBSTANCE ON THE WALL OF THE WASH WHEEL AND SALT SPILLS IN AND AROUND THE WASH WHEEL, BUT NOTED THAT NOTHING WAS LEAKING. THE FSE CLEANED ALL SPILLS AND RAN A SYSTEM CHECK. THE FSE HAD CUSTOMER RUN TEST SAMPLES AND QC WITH GOOD RESULTS. HARDWARE ISSUE MAY HAVE CONTRIBUTED TO THIS EVENT. HOWEVER, A CLEAR ROOT CAUSE 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 ERRONEOUSLY ELEVATED TROPONIN (ACCU TNI) RESULTS THAT THERE WERE GENERATED BY THE ACCESS 2 INSTRUMENT FOR A SINGLE PT SAMPLE. AN INITIAL ACCU TNI WAS 72.87NG/ML. THE RESULT WAS PRINTED WITH AN "ORH" FLAG (ORH-VALUE IS ELEVATED OUTSIDE THE REFERENCE RANGE). THE ORIGINAL SAMPLE WAS RE-TESTED AS A RESULT OF AN ESTABLISHED REFLEX CONDITION AND A RESULT OF 66.92NG/ML WAS OBTAINED. THE RESULT WAS FLAGGED WITH THE ORH FLAG. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LAB. THE SPECIMEN WAS SENT TO A DIFFERENT LAB FOR TROPONIN TESTING. TROPONIN RESULT FROM THE DIFFERENT LAB WAS "NEGATIVE", BUT THE ACTUAL RESULT WAS NOT SUPPLIED. BASED ON AVAIL INFO, THE CUSTOMER PROVIDED HAND WRITTEN NOTE STATING THAT "TREATMENT WAS AFFECTED SOMEHOW BECAUSE THERE WAS A DELAY IN THE RELEASE OF THE RESULTS FROM THE DIFFERENT LAB." NO INJURY OR DEATH OCCURRED IN CONJUNCTION WITH 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 IMMUNOASSAY SYSTEM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA