BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2099953 · Received May 23, 2011

    Report

    Report Number
    2122870-2011-01539
    Event Type
    Injury
    Date Received
    May 23, 2011
    Date of Event
    April 27, 2011
    Report Date
    April 29, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JHS
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLASSIFICATION PRODUCT CODE OF THE SUSPECT MEDICAL DEVICE INVOLVED WAS INCORRECTLY IDENTIFIED AS CGN IN THE ORIGINAL 3500A. THE CORRECT CLASSIFICATION PRODUCT CODE IS JJE. THE ORIGINAL OUTCOME WAS INCORRECTLY REFERENCED AS "LIFE THREATENING" AND "HOSPITALIZATION". THE CORRECT REFERENCE IS "HOSPITALIZATION" AND "REQUIRED INTERVENTION".

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED FOR THIS EVENT. AN INVESTIGATION IS UNDERWAY TO ATTEMPT TO DETERMINE THE ROOT CAUSE OF THIS EVENT. TO DATE, NO CLEAR ROOT CAUSE HAS BEEN DETERMINED. THE MDR ASSOCIATED WITH THIS EVENT CONSIST OF: 2122870-2011-01531.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 A CREATINE KINASE-MB ISOENZYME (CK-MB) RESULT ABOVE THE NORMAL REFERENCE RANGE WAS GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT SAMPLE. THE PATIENT WAS AN ALREADY ADMITTED HOSPITAL PATIENT. THE RESULT WAS REPORTED OUT OF THE LABORATORY. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) BASED UPON THE ERRONEOUSLY ELEVATED CK-MB RESULT. A RETEST OF THE SAMPLE ON (B)(6) 2011, ON THE SAME INSTRUMENT, GENERATED A LOWER CK-MB VALUE THAT WAS CONSIDERED VALID. QUALITY CONTROL RESULTS WERE PERFORMING WITHIN CUSTOMER ESTABLISHED RANGES AT THE TIME OF THE EVENT AND SYSTEM CHECKS WERE MEETING ESTABLISHED SPECIFICATIONS. THE CUSTOMER HAS INDICATED THAT ALL OTHER RESULTS GENERATED DURING THE TIMEFRAME OF THIS EVENT WERE REGARDED AS VALID. THE EVENT LOG DURING THE TIME OF THIS EVENT INDICATES THAT A "STATUS CONTROLLER INITIALIZATION ERROR" (WHICH IS AN ERROR DETECTED WHILE THE STATUS CONTROLLER IS INITIALIZING THE INSTRUMENT PARAMETERS) WAS GENERATED ON THE INSTRUMENT. THE NATURE OF THIS ERROR SUGGESTS THAT IT DID NOT OCCUR DURING PATIENT TESTING. A SERVICE CALL INVOLVING A HARD DISK ERROR WAS RECEIVED FROM THIS CUSTOMER ON (B)(4) 2011. THE INVOLVEMENT OF THIS ERROR IN RELATION TO THIS EVENT IS UNKNOWN AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R ACCESS CK-MB