BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2099949 · Received May 23, 2011

    Report

    Report Number
    2122870-2011-01530
    Event Type
    Malfunction
    Date Received
    May 23, 2011
    Date of Event
    April 27, 2011
    Report Date
    April 29, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 MDRS ASSOCIATED WITH THIS EVENT CONSIST OF: 2122870-2011-01529, 2122870-2011-01530.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 A GI MONITOR RESULT REPORTING OVR (OVER RANGE FLAG) WAS GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT SAMPLE. RETESTS OF VARYING DILUTIONS OF THE SAMPLE ON (B)(6) 2011, ON THE SAME INSTRUMENT, GENERATED MULTIPLE HIGH GI MONITOR RESULTS. THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY, AND HENCE THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION IN PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. RETESTS OF VARYING DILUTIONS OF THE SAMPLE ON (B)(6) 2011, ON THE SAME INSTRUMENT, GENERATED RESULTS OF 4447.2 U/ML AND 3056.9 U/ML. 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)(6) 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 JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS GI MONITOR