BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2072365 · Received April 29, 2011

    Report

    Report Number
    2122870-2011-01084
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 29, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION DEVICE AND CENTRIFUGATION INFORMATION HAS NOT BEEN SUPPLIED TO DATE. ACCUTNI QC PERFORMED ON THE MORNING OF THE EVENT WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES. SYSTEM CHECKS ARE PERFORMING WITHIN INSTRUMENT SPECIFICATIONS. THE ON-BOARD ACCUTNI REAGENT PACK WAS LISTED AS HAVING 22 TESTS LEFT IN THE INSTRUMENT SOFTWARE. HOTLINE INSTRUCTED THE CUSTOMER TO: REMOVE THE ON-BOARD ACCUTNI PACK AND THEN RE-LOAD IT. RUN ACCUTNI QC ON THE POTENTIALLY MIS-LOADED PACK, ALL RESULTS REPRODUCED AT 0.00NG/ML, CONFIRMING THE PACK HAD NOT BEEN LOADED PROPERLY. TO REMOVE THE ON-BOARD ACCUTNI PACK AND TO LOAD A NEW ACCUTNI REAGENT PACKS. PERFORM ACCUTNI QC ON THE NEW REAGENT PACK. THE CUSTOMER PERFORMED ACCUTNI QC WITHIN THEIR ESTABLISHED LIMITS AFTER THEY HAD LOADED AND RAN ON THE NEW ACCUTNI REAGENT PACK. SERVICE HAS NOT BEEN DISPATCHED IN CONNECTION TO THIS EVENT TO DATE. USER ERROR IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) HOTLINE TO REPORT ONE PATIENT SAMPLE AND QC SAMPLES GAVE NEGATIVE RESULTS ON THE ACCUTNI ASSAY WHICH WERE GENERATED BY THE ACCESS 2 SYSTEM. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE ERRONEOUS SAMPLE WAS SENT TO THE CUSTOMER'S ALTERNATE LAB WHILE TROUBLESHOOTING WITH HOTLINE AND BACK UP LAB AND THE INITIAL RESULT OF 0.00NG/ML WAS NOT REPORTED OUT. 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 SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. ACCESS 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1