BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 947714 · Received November 8, 2007

    Report

    Report Number
    2122870-2007-00251
    Event Type
    Other
    Date Received
    November 8, 2007
    Date of Event
    October 20, 2007
    Report Date
    November 8, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN A NON-GEL, BD, GLASS LITHIUM HEPARIN TUBE AND CENTRIFUGED AT 6,000 RCF FOR 6 MINUTES. BASED ON AVAILABLE INFO, THE SAMPLE APPEARANCE WAS STRAW COLORED AND CLEAR. QC WAS WITHIN SPECIFICATIONS PRIOR TO THE EVENT. A SYSTEM CHECK PERFORMED IN 2007, WAS WITHIN SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB THREE DAYS LATER: THE FSE HAD CUSTOMER RUN A SYSTEM CHECK PRIOR TO ARRIVAL AND A WASHED CV WAS WITHIN SPECIFICATIONS, BUT HIGH. THE FSE INSPECTED THE INSTRUMENT AND FOUND BENT ASPIRATE PROBE AND DROPLETS ON THE DISPENSE PROBES. THE FSE NOTED THAT WASH VALVE HAD MULTIPLE MOTION ERRORS. THE ROTOR SHAFT WAS REPLACED AND ERRORS SUBSIDED. THE FSE PERFORMED A PREVENTIVE MAINTENANCE (PM) TO THE INSTRUMENT (PM WAS SOON DUE). THE FSE REPLACED A SLIGHTLY BENT MAIN PIPETTOR. THE FSE CONDUCTED A DIAGNOSTIC TESTING WHICH PASSED. THE FSE VERIFIED THE INSTRUMENT PER ESTABLISHED PROCEDURES. TREATMENT WAS NOT AFFECTED IN THIS EVENT. ON A RECUR, TREATMENT MAY BE WITHHELD BASED ON THE FALSE LOW ACCU TNI RESULT OBTAINED. HARDWARE ISSUES MAY HAVE CONTRIBUTED TO THIS EVENT. 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 LOW TROPONIN (ACCU TNI) RESULT THAT WAS GENERATED BY THE ACCESS 2 INSTRUMENT. A PT SAMPLE WAS TESTED FOR ACCU TNI AND A RESULT OF "NO VALUE IND" (IND= INDETERMINATE) WAS OBTAINED. THE SAMPLE WAS RE-TESTED AND ACCU TNI RESULT WAS 0.11NG/ML. THE ORIGINAL SAMPLE WAS TESTED FOR ACCU TNI ON A DIFFERENT INSTRUMENT IN THE CUSTOMER'S LAB AND A RESULT OF 0.61NG/ML WAS OBTAINED. IN 2007, CUSTOMER STATED THE 0.61 NG/ML ACCU TNI RESULT WAS BELIEVED TO BE A TRUE RESULT FOR THE PT. THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LAB AND CUSTOMER DID NOT RECEIVE ANY REPORT OF 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 JJE BECKMAN COULTER, INC. ACCESS 2 IMMUNOASSAY SYSTEM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA