BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1914517 · Received December 3, 2010

    Report

    Report Number
    2122870-2010-00853
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 10, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE ARE VENOUS DRAWS. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGE PRE AND POST THE EVENT. A BCI FIELD SERVICE ENGINEER (FSE) PERFORMED THE FOLLOWINGS: A SYSTEM CHECK, HIGH SENSITIVITY SYSTEM CHECK AND PRECISION RUN; ALL RUNS PERFORMED PASSED. COMPLETED PREVENTIVE MAINTENANCE AFTER THE INITIAL SYSTEM VERIFICATION RUNS. RERAN SYSTEM CHECK AND QC. ALL TEST PASSED. VERIFIED REPAIR PER ESTABLISHED PROCEDURES. RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. FSE DID NOT IDENTIFY ANY HARDWARE ISSUES ASSOCIATED WITH THIS EVENT. A CLEAR ROOT CAUSE CAN NOT BE DETERMINED FOR THIS EVENT. FROM : DATE: 11/05/2010, PATIENT/SAMPLE : 1/1, ACCESS RUN RESULT: 15.2, REPEAT RUN: RESULT ON SAME UNIT: 1.6, REPEAT RUN RESULTS ON ALTERNATE UNIT: 1.7. TO: DATE: 11/08/2010, PATIENT/SAMPLE: 1/1, ACCESS RUN RESULT: 15.2, REPEAT RUN RESULT ON SAME UNIT: 1.6, REPEAT RUN RESULTS ON ALTERNATE UNIT: 1.7.

    Additional Manufacturer Narrative · 1

    THE SAMPLE ARE VENOUS DRAWS QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGE PRE AND POST THE EVENT. A BCI FIELD SERVICE ENGINEER (FSE) PERFORMED THE FOLLOWINGS: AN SYSTEM CHECK, HIGH SENSITIVITY SYSTEM CHECK AND PRECISION RUN; ALL RUNS PERFORMED PASSED. COMPLETED PREVENTIVE MAINTENANCE AFTER THE INITIAL SYSTEM VERIFICATION RUNS. RERAN SYSTEM CHECK AND QC. ALL TEST PASSED. VERIFIED REPAIR PER ESTABLISHED PROCEDURES. RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. FSE DID NOT IDENTIFY ANY HARDWARE ISSUES ASSOCIATED WITH THIS EVENT. A CLEAR ROOT CAUSE CAN NOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS HIGH CK-MB RESULT ON ONE PATIENT GENERATED BY ACCESS 2 IMMUNOASSAY ANALYZER. THE RESULT WAS REPORTED OUT OF THE LABORATORY. THE SAMPLE WAS REPEATED ON THE SAME UNIT AND AN ALTERNATE UNIT. LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE WERE OBTAINED FROM BOTH UNITS. PATIENT RESULTS ARE PROVIDED. PER CUSTOMER, NO INJURY OR CHANGE IN TREATMENT WAS ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS HIGH CK-MB RESULT ON ONE PATIENT GENERATED BY ACCESS 2 IMMUNOASSAY ANALYZER. THE RESULT WAS REPORTED OUT OF THE LABORATORY. THE SAMPLE WAS REPEATED ON THE SAME UNIT AND AN ALTERNATE UNIT. LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE WERE OBTAINED FROM BOTH UNITS. PER CUSTOMER, NO INJURY OR CHANGE IN TREATMENT WAS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. ACCESS 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1