BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1234067 · Received November 4, 2008

    Report

    Report Number
    2122870-2008-00345
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    October 10, 2008
    Report Date
    November 4, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER COLLECTS SAMPLES IN PLASTIC BD SODIUM HEPARIN TUBES. SAMPLES ARE CENTRIFUGED AT 3,000 RPM FOR 5 MINUTES. THE SPECIMENS WERE NORMAL IN APPEARANCE AND WERE SAMPLED FROM THE PRIMARY TUBES. THE SAMPLES WERE STORED REFRIGERATED UNTIL REPEAT TESTING WAS DONE. QC WAS WITHIN SPECIFICATIONS DURING THE TIME OF THE EVENT. A SYSTEM CHECK PERFORMED ON (B)(6) 2008 MET SPECIFICATIONS. THE CUSTOMER STATED THERE WERE NO FATAL ERRORS POSTED TO THE EVENT LOG. INITIALLY, THE CUSTOMER DECLINED SERVICE FOR THIS EVENT STATING THAT A PREVENTIVE MAINTENANCE (PM) WAS RECENTLY PERFORMED ((B)(6) 2008). THE CUSTOMER CONTACTED CUSTOMER TECHNICAL SERVICE (CTS) ON (B)(6) 2008 AND IT WAS RECOMMENDED THAT SERVICE EVALUATE THE INSTRUMENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE VERIFIED THE INSTRUMENT TO BE IN WORKING ORDER. THE FSE PERFORMED A DIAGNOSTIC TESTING WHICH PASSED. THE FSE NOTED THE CUSTOMER'S CENTRIFUGE TIME IS SET AT 5 MINUTES. THE FSE PROVIDED THE CUSTOMER WITH BD DOCUMENTATION THAT RECOMMENDS A 10 MINUTE CENTRIFUGE TIME. THE FSE NOTED THE CUSTOMER USES BD GREEN TOP TUBES WITHOUT A GEL BARRIER AND RECOMMENDED THE CUSTOMER USE TUBES WITH GEL. THE FSE DISCUSSED PRE-ANALYTICAL SAMPLE HANDLING WITH THE CUSTOMER. THE FSE VERIFIED THE INSTRUMENT PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. ROOT CAUSE FOR THIS EVENT 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 ERRONEOUSLY ELEVATED TROPONIN (ACCU TNI) RESULTS WITHIN THE RISK STRATIFICATION RANGE, GENERATED BY THE ACCESS 2 INSTRUMENT FOR THREE PATIENTS. PATIENT A, B, AND C SAMPLES WERE TESTED FOR ACCU TNL AND RESULTS OF 0.21NG/ML, 0.35NG/ML, AND 0.15NG/ML WERE OBTAINED RESPECTIVELY. THE RESULTS WERE REPORTED OUT OF THE LAB. THE ORIGINAL SAMPLES WERE RE-TESTED AND RESULTS RECOVERED IN THE NORMAL RANGE FOR ALL THREE PATIENTS. BASED ON INFORMATION PROVIDED, ONE PATIENT WAS STARTED ON CLAVIX TREATMENT. HOWEVER, NO INFORMATION WAS SUPPLIED TO INDICATE WHICH PATIENT STARTED THE MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. IMMUNOASSAY SYSTEM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA