BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS2 IMMUNOASSAY SYSTEM

    MDR report key: 1030415 · Received April 17, 2008

    Report

    Report Number
    2122870-2008-00124
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    March 26, 2008
    Report Date
    April 17, 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
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN SPECIFICATIONS ON THE DATES OF THE EVENTS. A SYSTEM CHECK PERFORMED IN 2008 WAS WITHIN SPECIFICATIONS. THE SPECIMENS WERE COLLECTED IN 12X75 LITHIUM HEPARIN GEL TUBES. THE SAMPLES WERE CENTRIFUGED AT "<5,000" RPM FOR ">5" MINUTES. THE 4TH SAMPLE WAS TESTED USING A HETEROPHILE BLOCKING AGENT. NO INTERFERENCE WAS DETECTED AND THE SAMPLE WAS REPRODUCIBLE GIVING A RESULT OF 0.24NG/ML. A FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED TO THE CUSTOMER'S LAB: SERVICE WAS DECLINED BY THE CUSTOMER AS THERE WERE NO ISSUES WITH OTHER PT RESULTS. 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 GENERATED BY THE ACCESS2 INSTRUMENT FOR A SINGLE PT. IN 2008, A PT HAS BEEN DRAWN MULTIPLE TIMES AND TESTED FOR ACCU TNI: TWO (2) SAMPLES TESTED FOR ACCU TNI THE FIRST TIME, GAVE RESULTS OF 0.90NG/ML AND 0.87NG/ML RESPECTIVELY. A 3RD SAMPLE WAS COLLECTED ON THE NEXT DAY AND A RESULT OF 0.64NG/ML WAS OBTAINED. ANOTHER SAMPLE (4) GAVE AN ACCU TNI RESULT OF 0.25NG/ML. A FIFTH SAMPLE GAVE A RESULT OF 0.16NG/ML. CUSTOMER SENT THIS SPECIMEN TO ANOTHER LAB FOR TROPONIN TESTING BY A DIFFERENT METHOD AND A RESULT OF "<0.05NG/ML" WAS OBTAINED. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB AND QUESTIONED. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER, INC. ACCESS2 IMMUNOASSAY SYSTEM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA