BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2618755 · Received June 17, 2012

    Report

    Report Number
    2122870-2012-01491
    Event Type
    Malfunction
    Date Received
    June 17, 2012
    Date of Event
    May 22, 2012
    Report Date
    May 22, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: ROOT CAUSE IS UNKNOWN. EXCESS FLUID IN THE WASH CAROUSEL CAN LEAD TO ELEVATED DARK COUNTS AND ELEVATED RLU READINGS. REAGENTS USED IN CONJUNCTION WITH THE ACCESS 2 IMMUNOASSAY SYSTEM: CATALOG NO.: 33345, BRAND NAME: ACCESS ACCUTNI CALIBRATORS (S0-S5), 1 SET, 6 X 1.0 ML; CATALOG NO.: A78803, BRAND NAME: ACCESS ACCUTNI REAGENT PACK, 100 DETERMINATIONS, 2 X 50 TESTS; CATALOG NO.: 973243, BRAND NAME: ACCESS MYOGLOBIN, 2 X 50 DETERMINATIONS, LOT NUMBER: 123587; CATALOG NO.: 973244, BRAND NAME: ACCESS MYOGLOBIN CALIBRATORS, LOT NUMBER: 119486.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE ACCESS 2 IMMUNOASSAY SYSTEM (ACCESS 2) GAVE DARK COUNT ERRORS. CUSTOMER REPORTED THAT THE ACCESS 2 SYSTEM GENERATED ERRONEOUS RESULTS ON MULTIPLE PATIENTS. CUSTOMER REPORTED THAT EIGHT TROPONIN RESULTS WERE >95 NG/ML. CUSTOMER REPORTED THAT THE ACCESS 2 GAVE OVR (OVER RANGE) FLAGS FOR THE TROPONIN RESULTS. CUSTOMER REPORTED THAT THE TROPONIN RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. CUSTOMER REPORTED THAT MYOGLOBIN TESTS WERE ALSO RUN ON THE SAME PATIENT SAMPLES AND TWO RESULTS WERE AUTO RELEASED FROM THE LABORATORY. CUSTOMER REPORTED THAT ALL THE SAMPLES WERE REPEATED ON ANOTHER ACCESS 2 AND THE MYOGLOBIN RESULTS DID NOT REPEAT. CUSTOMER INDICATED THAT THERE WERE NO QUALITY CONTROL ISSUES PRIOR TO THE ERRONEOUS RESULTS. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. CUSTOMER ALSO REQUESTED THAT BEC DISPATCH SERVICE FOR A NOISY PUMP. BEC INVESTIGATION INDICATES SYSTEM CHECKS FAILED AFTER THE ERRONEOUS RESULTS. BEC FIELD SERVICE ENGINEER (FSE) CONFIRMED HIGH DARK COUNT ERRORS IN THE EVENT LOG. THE FSE INSPECTED THE VACUUM SYSTEM, WASH ARM AND PROBES, THE ASPIRATE AND DISPENSE VOLUMES AND FOUND ALL COMPONENTS WERE WITHIN SPECIFICATIONS. THE FSE NOTICED A SIGNIFICANT AMOUNT OF LIQUID INSIDE THE WASH CAROUSEL. AFTER CLEANING THE LIQUID FROM THE WASH CAROUSEL, THE DARK COUNT TEST WAS LESS THAN TEN RELATIVE LIGHT UNITS (RLUS). THE FSE THEN RAN A PASSING SYSTEM CHECK AND RAN A PASSING QUALITY CONTROL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1