BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2172329 · Received July 22, 2011

    Report

    Report Number
    2122870-2011-02365
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERVICE WAS DISPATCHED FOR THIS EVENT. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 "NO VALUE" CARDIAC TROPONIN (ACCUTNI) RESULTS WITH INDETERMINATE (IND) INSTRUMENT FLAGS WERE GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM FOR TWO PATIENT SAMPLES. ERRONEOUS RESULTS WERE NOT RELEASED FROM THE LABORATORY AND HENCE THERE WERE NO DEATHS, SERIOUS INJURIES OR MODIFICATIONS TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. NO PATIENT INFORMATION, INSTRUMENT SYSTEM CHECK INFORMATION OR SAMPLE PREPARATION/HANDLING INFORMATION WAS PROVIDED BY THE CUSTOMER. A REVIEW OF CUSTOMER SUPPLIED SYSTEM DATA REVEALED THAT THE S0 CALIBRATOR RELATIVE LIGHT UNITS (RLUS) AT THE TIME OF THE EVENT WERE APPROXIMATELY 2 TIMES HIGHER THAN IN-HOUSE QUALITY CONTROL RELEASE DATA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS ACCUTNI - REAGENT