BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1022613 · Received March 31, 2008

    Report

    Report Number
    2122870-2008-00101
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Date of Event
    March 14, 2008
    Report Date
    March 31, 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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC LEVELS I AND II WERE WITHIN SPECIFICATIONS PRIOR TO THE EVENT. QC LEVEL I WAS OUT OF SPECIFICATIONS HIGH AFTER THE EVENT. A NEW ALIQUOT OF QC LEVEL I WAS MADE AND RUN THREE TIMES WITH GOOD RESULTS. QC LEVEL III WAS RUN FOLLOWING THE EVENT AND RECOVERED WITHIN RANGE. A SYSTEM CHECK PERFORMED IN 2008 PASSED. A SYSTEM CHECK CONDUCTED ON TWO DAYS LATER WAS OUT OF SPECIFICATIONS. PER CUSTOMER, NO ADVERSE EVENTS WERE POSTED TO THE EVENT LOG. THE CUSTOMER COLLECTS SAMPLES IN PLASTIC BD, LITHIUM HEPARIN TUBES WITH GEL AND CENTRIFUGES SAMPLES AT 2,500 RPM FOR 10 MINS AT ROOM TEMPERATURE. THE SPECIMEN WAS ALIQUOTED AND THEN SAMPLED FROM PLASTIC 13 X 75 POUR-OFF TUBE. A FIELD SVC ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB ON THE SAME DAY: THE FSE NOTED SYSTEM CHECK RUN TWICE WITH TWO DIFFERENT SETS OF ASPIRATE PROBES FAILED. THE FSE INSPECTED THE INSTRUMENT AND DISCOVERED THAT PERI-PUMP TUBING TO ASPIRATE PROBE #4 HAD BEEN PINCHED AND HAD A PIN-HOLE LEAK. THE FSE REPLACED THE ASPIRATE PUMP TUBING AND CLEANED THE PROBES. THE CUSTOMER RECALIBRATED THE INSTRUMENT FOR ACCU TNI AND RAN QC; RESULTS RECOVERED WITHIN RANGE. IN A FOLLOW-UP WITH THE CUSTOMER ON THE NEXT DAY, THEY STATED THAT QC AND PT SAMPLES WERE RUNNING WITHOUT PROBLEMS. ALTHOUGH HARDWARE ISSUES MAY HAVE CONTRIBUTED TO THIS EVENT, A CLEAR ROOT CAUSE IS UNKNOWN AT THIS TIME. 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 AN ERRONEOUSLY ELEVATED TROPONIN (ACC TNI) RESULT THAT WAS GENERATED BY THE ACCESS 2 INSTRUMENT FOR A SINGLE PT SAMPLE. AN INITIAL ACCU TNI RESULT WAS 0.36NG/ML AND 0.60NG/ML UPON REPEAT. THE ORIGINAL SAMPLE WAS RE-CENTRIFUGED AND THEN RE-TESTED, AND 3 RESULTS OF 0.01NG/ML WERE OBTAINED. IT IS UNCLEAR IF THE RESULTS WERE REPORTED OUT OF THE LAB. THE CUSTOMER DID NOT REPORT PT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PT TREATMENT ATTRIBUTED OR CONNECTED WITH 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