BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS HYPERSENSITIVE HTSH

    MDR report key: 3898475 · Received June 26, 2014

    Report

    Report Number
    8020879-2014-00005
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 2, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JLW
    PMA / PMN Number
    K042281
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER (BEC) FIELD SERVICE WAS NOT DISPATCHED; THE CUSTOMER HAS A CONTRACT FOR FIELD SERVICE WITH A DIFFERENT COMPANY. ASSOCIATED MDR: 8020879-2014-00006.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUS THYROID-STIMULATING HORMONE (HTSH) RESULTS WERE GENERATED FOR ONE PATIENT ON TWO INSTRUMENTS. THIS MDR REPORTS THE RESULTS GENERATED ON A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM; PLEASE SEE MDR 8020879-2014-00006 FOR THE RESULTS GENERATED ON A UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM. THE PATIENT SAMPLE WAS INITIALLY ANALYZED ON A UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM AND THE HTSH RESULT WAS BELOW THE LABORATORY'S NORMAL REFERENCE RANGE. THE CUSTOMER RETESTED THE SAMPLE SEVERAL TIMES ON THE SAME INSTRUMENT AND ON A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM IN THE SAME LABORATORY; HTSH RESULTS WERE BELOW, WITHIN, AND ABOVE THE REFERENCE RANGE. A RERUN RESULT WITHIN THE NORMAL REFERENCE RANGE WAS REPORTED OUT OF THE LABORATORY. THERE WAS NO CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. A REVIEW OF QUALITY CONTROL (QC) DATA SHOWS THAT HTSH QC RESULTS WERE WITHIN THE LABORATORY'S ESTABLISHED RANGE ON THE DATE OF THE EVENT. THE CUSTOMER DID NOT REPORT ANY SAMPLE QUALITY ISSUES. THE INSTRUMENT HAD BEEN CALIBRATED WITH ACCESS HTSH CALIBRATOR LOT 333848.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373668 ACCESS HYPERSENSITIVE HTSH RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW BECKMAN COULTER NA 423688

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR