BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® IMMUNOASSAY ANALYZER

    MDR report key: 1971754 · Received January 27, 2011

    Report

    Report Number
    2122870-2011-00128
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    December 28, 2010
    Report Date
    December 28, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922826
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE BCI CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER TROUBLESHOOTING, IT WAS FOUND THAT THE REAGENT PACK WAS SHARED BETWEEN TWO ACCESS SYSTEMS. THE PRODUCT LABELING GIVES INSTRUCTIONS NOT TO LOAD A PARTIALLY USED REAGENT PACK ON A DIFFERENT INSTRUMENT. SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE LIKELY ROOT CAUSE WAS DISCOVERED WHILE TROUBLESHOOTING WITH CTS.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED ERRONEOUS TROPONIN (ACCUTNI) RESULTS OF 0.01 NG/ML FOR QC AND FAILED ACCUTNI CALIBRATIONS ON ACCESS IMMUNOASSAY ANALYZER. THERE IS NO INDICATION THAT THERE WERE ANY PATIENT RESULTS OBTAINED AT THE TIME OF THIS EVENT. THE CUSTOMER DID NOT RECEIVE ANY REPORTS OF DEATH, 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® IMMUNOASSAY ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1