BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 947723 · Received November 12, 2007

    Report

    Report Number
    2122870-2007-00260
    Event Type
    Other
    Date Received
    November 12, 2007
    Date of Event
    October 26, 2007
    Report Date
    November 12, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN WAS COLLECTED IN A BD, LITHIUM HEPARIN TUBE AND CENTRIFUGED AT 5,600 RPM FOR 5 MINUTES. QC WAS WITHIN SPECIFICATIONS PRIOR TO THE EVENT. SYSTEM CHECK INFORMATION, PROVIDED FROM 10/21/2007, WAS WITHIN SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: A) THE FSE RAN FIELD VERIFICATION PROCEDURES WHICH MET SPECIFICATIONS. B) THE FSE RE-CENTRIFUGED THE SAMPLE AND NOTED A RED CELL BUTTON ON THE BOTTOM OF THE TUBE. C) THE FSE RAN PRECISION RUN WITH THIS SAMPLE AND OBTAINED GOOD RESULTS. D) THE FSE REVIEWED PROPER PRE-ANALYTICAL SAMPLE HANDLING PROCEDURES WITH THE CUSTOMER. IN A FOLLOW UP WITH THE CUSTOMER, THE FSE REVIEWED AGAIN PROPER SAMPLE HANDLING AND TECHNIQUE. PER CUSTOMER, THEY HAVE NOT HAD ANY ADDITIONAL ISSUES SINCE THIS OCCURRENCE. PRE-ANALYTICAL SAMPLE HANDLING 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 ERRONEOUSLY ELEVATED TROPONIN (ACCU TNI) RESULTS THAT WERE GENERATED BY THE ACCESS 2 INSTRUMENT. A PATIENT SAMPLE WAS TESTED FOR ACCU TNI AND AN INITIAL RESULT WAS 1.71NG/ML, AND 0.06NG/ML UPON REPEAT. THE SAMPLE WAS RE-TESTED THE SAME DAY AND ACCU TNI RESULTS WERE: 1.19NG/ML, 0.06NG/ML AND 0.01NG/ML. THE ORIGINAL SAMPLE WAS TESTED FOR ACCU TNI AT SISTER'S LAB AND 3 RESULTS OF 0.02NG/ML WERE OBTAINED. THE ACCU TNI RESULTS WERE NOT REPORTED OUT OF THE LAB, AND CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO 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 YR