BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® IMMUNOASSAY ANALYZER

    MDR report key: 1832602 · Received September 13, 2010

    Report

    Report Number
    2122870-2010-00527
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 17, 2010
    Report Date
    September 13, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DHA
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO THE EVENT AND WAS PRODUCING NO VALUE RESULTS AFTER THE EVENT. WHILE TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT (CTS), 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. SERVICE WAS NOT DISPATCHED AS THE ISSUE WAS RESOLVED BY TROUBLESHOOTING WITH THE CTS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC.(BCI) IN REGARDS TO NO VALUE RESULTS GENERATED ON ACCESS IMMUNOASSAY ANALYZER FOR MULTIPLE PATIENTS AND QC FOR TOTAL BETA HCG (TBHCG). THE RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER DID NOT RECEIVE ANY REPORT 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 DHA BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1