BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2122477 · Received June 13, 2011

    Report

    Report Number
    2122870-2011-01869
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 14, 2011
    Report Date
    May 14, 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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE PLASMA. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED ON (B)(6) 2011. QC WAS NOT PERFORMED FOR THE DAY OF (B)(6) 2011 PRIOR TO THE ERRONEOUS RESULTS. NO ERRORS OR FLAGS ASSOCIATED WITH THE ERRONEOUSLY LOW CKMB RESULTS. THE CUSTOMER LOADED A NEW REAGENT PACK, RERAN THE SAMPLE AND OBTAINED RESULTS THAT MATCHED THE PATIENT'S INITIAL RESULTS OF APPROXIMATELY 5 NG/ML. DIAGNOSTIC COPY TO DISK DATA FROM BOTH INSTRUMENTS INDICATES PACK (B)(4) WAS USED ON BOTH ACCESS 2 INSTRUMENTS. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. USE ERROR IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING LOWER THAN EXPECTED RESULTS FOR TWO PATIENTS' SAMPLES FOR CK-MB GENERATED BY THE ACCESS 2 IMMUNOASSAY ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. ONE OF THE SAMPLES WAS REPEATED ON THE SAME INSTRUMENT A HIGHER RESULT WAS OBTAINED. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION 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