BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM.

    MDR report key: 2052384 · Received April 12, 2011

    Report

    Report Number
    2122870-2011-00975
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 13, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES ARE LI HEPARIN PLASMA. SAMPLES ARE ASPIRATED FROM THE PRIMARY COLLECTION TUBES FOR ANALYSIS. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO THE ERRONEOUS RESULTS. A SYSTEM CHECK WAS PERFORMED ON (B)(6) 2011 AND MET SPECIFICATIONS. THE CUSTOMER INDICATED THAT A HIGHLY CONCENTRATED ACCUTNI SAMPLE HAD BEEN RUN PRIOR TO THE PATIENT SAMPLES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 FOR THIS EVENT. THE FSE PERFORMED MAINTENANCE AND THE CARRYOVER PROCEDURE AND THE CARRYOVER TEST MET SPECIFICATIONS. THE FSE PERFORMED THE SPECIAL CLEAN PROCEDURE. PATIENT CONTROLS IN THE NORMAL REFERENCE RANGE WERE ANALYZED AND RESULTED HIGHER WITHIN THE RISK STRATIFICATION RANGE. THE FSE THEN REPLACED THE ASPIRATE PROBES, SAMPLE PIPETTOR, PERI PUMP TUBING AND THE REAGENT PACK. THE PATIENT CONTROLS WERE REANALYZED AND RESULTED WITHIN THE NORMAL REFERENCE RANGE. VERIFICATION TESTING WAS PERFORMED AND MET SPECIFICATION. USER ERROR IS THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING TROPONIN (ACCUTNI) RESULTS WITHIN THE RISK STRATIFICATION RANGE ON EIGHT (8) PATIENTS' SAMPLES THAT WERE QUESTIONED BY PHYSICIANS, GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. REPEAT RESULTS PERFORMED AFTER THE INSTRUMENT WAS SERVICED, WERE WITHIN THE NORMAL REFERENCE RANGE AND LOWER WITHIN THE RISK STRATIFICATION RANGE. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1