BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 902651 · Received August 23, 2007

    Report

    Report Number
    2122870-2007-00197
    Event Type
    Other
    Date Received
    August 23, 2007
    Date of Event
    August 6, 2007
    Report Date
    August 23, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC PERFORMED PRIOR TO THE EVENT RESULTED WITHIN THE CUSTOMER'S ESTABLISHED RANGE. A SYSTEM CHECK PERFORMED IN 2007, WAS WITHIN SPECS. THERE WAS NO INDICATION OF ERRORS BEING RECEIVED IN THE EVENT LOG. THE SPECIMENS WERE COLLECTED IN LITHIUM HEPARIN PLASMA WITH GEL TUBES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: THE FSE CONDUCTED A DIAGNOSTIC TESTING AND RESULTS MET SPECS. THE FSE SUGGESTED CUSTOMER PERFORMS A 20 REPLICATE PRECISION RUN AND RESULTS WERE ACCEPTABLE. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED FOR 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. TWO DAYS IN 2007, FOUR (4) SAMPLES FROM A PT WERE TESTED FOR ACCU TNI: SAMPLE A: THE INITIAL RESULT WAS 0.55NG/ML AND 0.12NG/ML UPON REPEAT. SAMPLE B: THE INITIAL RESULT WAS 0.11NG/ML. THE SAMPLE WAS RE-CENTRIFUGED AND THEN RE-TESTED. THE REPEATED RESULTS WERE IN THE RANGE OF 0.02NG/ML TO 0.04NG/ML. SAMPLE C: THE INITIAL RESULT WAS 0.02NG/ML. THE SAMPLE WAS TESTED ON A DIFFERENT INSTRUMENT IN THE CUSTOMER'S LAB AND THE RESULT WAS ALSO 0.02NG/ML. SAMPLE D: THE INITIAL RESULT WAS 5.34NG/ML AND 0.15NG/ML UPON REPEAT. IT IS NOT CLEAR IF THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB. BASED ON AVAILABLE INFO, THE PT WAS ADMITTED TO ICU. HOWEVER, THERE WAS NO REPORT OF PT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PT TREATMENT RECEIVED REGARDING 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 YR