BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM

    MDR report key: 1838298 · Received September 17, 2010

    Report

    Report Number
    2122870-2010-00547
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 23, 2010
    Report Date
    September 17, 2010
    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
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE COLLECTED IN 13X75MM PLASTIC LITHIUM HEPARIN PLASMA TUBES WITH A GEL SEPARATOR, AND WERE CENTRIFUGED FOR 3 MINUTES AT 4400 RPM AT ROOM TEMPERATURE. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. THE RESULTS OF SYSTEM CHECKS HAVE BEEN WITHIN THE INSTRUMENT SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2010. FSE VERIFIED SOME HARDWARE COMPONENTS, AND PERFORMED A SYSTEM CHECK. THE RESULTS MET PUBLISHED SPECIFICATIONS. NO HARDWARE ISSUE WAS NOTED. A DEFINITIVE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULTS ABOVE AMI CUT-OFF GENERATED ON ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING PRODUCED RESULTS WITHIN THE NORMAL REFERENCE RANGE. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1