BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 2179450 · Received July 27, 2011

    Report

    Report Number
    2122870-2011-02512
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    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
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SAMPLES WERE COLLECTED IN LIHEP PLASMA TUBES AND CENTRIFUGED FOR 5 MINUTES IN A STAT SPIN CENTRIFUGE. PER THE CUSTOMER, QC WAS PERFORMING WITHIN THE CUSTOMER'S ESTABLISHED LIMITS ON THE DATE OF EVENT. THE CUSTOMER DID NOT PROVIDE SYSTEM CHECK DATA. ON (B)(6) 2011, A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THE EVENT. THE FSE PERFORMED A SYSTEM CHECK, HIGH SENSITIVITY SYSTEM CHECK, AND BOTH PASSED WITHIN INSTRUMENT SPECIFICATIONS. THE CUSTOMER ALSO PERFORMED QC WHICH WAS WITHIN THEIR ESTABLISHED RANGES. NO HARDWARE REPAIRS WERE COMPLETED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT OBTAINING AN ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULT WITHIN THE RISK STRATIFICATION RANGE FOR ONE (1) PATIENT. THE RESULT WAS GENERATED BY AN ACCESS 2 IMMUNOASSAY ANALYZER, USED IN CONJUNCTION WITH ACCESS ACCUTNI REAGENT (LOT 023755). THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LAB. REPEAT ANALYSIS OF THE PATIENT'S SAMPLE PRODUCED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE. IT IS UNKNOWN IF THERE HAVE BEEN ANY CHANGES MADE TO PATIENT TREATMENT, THE CUSTOMER WAS UNABLE TO PROVIDE THE INFORMATION. IT WAS REPORTED THAT NO DEATH OR SERIOUS INJURY OCCURRED IN CONNECTION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE MMI BECKMAN COULTER, INC. ACCESS® 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR