BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2060397 · Received April 15, 2011

    Report

    Report Number
    2122870-2011-01011
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 18, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION HAS NOT BEEN SUPPLIED TO DATE. QC HAS BEEN FAILING EVER SINCE THE LAST PREVENTIVE MAINTENANCE (PM) PROCEDURE WAS PERFORMED ON THE INSTRUMENT. SYSTEM CHECK INFORMATION HAS NOT BEEN SUPPLIED TO DATE. A BCI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND DISCOVERED THAT THE TUBING HAD BECOME PINCHED IN THE TOP COVER OF THE INSTRUMENT AFTER IT HAD BEEN CLOSED. THE FSE WAS NOT CERTAIN WHICH TUBING WAS PINCHED OR HOW IT BECAME PINCHED IN THE COVER. THE PINCHED TUBING IS THE LIKELY ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING SEVERAL IND AND OVR FLAGGED PATIENT AND QC RESULTS AFTER HAVING A PREVENTIVE MAINTENANCE (PM) PERFORMED ON THE ACCESS 2 IMMUNOASSAY SYSTEM. PER THE CUSTOMER, SEVERAL OF THE PATIENTS' RESULTS OBTAINED WERE QUESTIONED BY THE CUSTOMER DUE TO BEING FLAGGED AS EITHER IND OR OVR. ALSO, SEVERAL ADDITIONAL PATIENT RESULTS OBTAINED WERE ALSO QUESTIONED BECAUSE THE RESULTS WERE EITHER TOO LOW OR TOO HIGH AND DID NOT MATCH THE PATIENTS' CLINICAL PICTURES. NO SPECIFIC PATIENT RESULTS WERE PROVIDED BY THE CUSTOMER. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1