BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 3163666 · Received June 11, 2013

    Report

    Report Number
    2122870-2013-00534
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER RESOLVED THE ISSUE THROUGH SYSTEM TROUBLESHOOTING VIA THE TELEPHONE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THREE SAMPLE COUNT OUTSIDE LIMITS SYSTEM ERRORS AND ELEVATED PERCENT COEFFICIENT OF VARIATION (%CV) WHILE ATTEMPTING TO CALIBRATE THE THYROID-STIMULATING HORMONE (TSH) ASSAY INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM. DURING SYSTEM TROUBLESHOOTING, THE CUSTOMER DISCOVERED THE CAP FITTINGS, TO THE SUBSTRATE BOTTLE, WERE EXTREMELY LOOSE. THE CUSTOMER STATED NO PATIENT SAMPLES WERE ANALYZED AT THE TIME OF THE EVENT. IT IS UNKNOWN WHEN THE FITTINGS CAME LOOSE FROM THE SUBSTRATE BOTTLE. THE CUSTOMER DID NOT REPORT ANY ISSUES WITH QUALITY CONTROL (QC) OR PATIENT RESULTS FROM PREVIOUS DAYS. THE CUSTOMER REPLACED THE IN-USE BOTTLE OF SUBSTRATE AND TIGHTENED THE CAP AND PRIMED THE SUBSTRATE SYSTEM TO RESOLVE THE ISSUE. A SUCCESSFUL SYSTEM CHECK AND TSH CALIBRATION WERE OBTAINED. NO ERRONEOUS PATIENT RESULTS WERE RELEASED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT CONSEQUENCE OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264281 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1