BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS HYPERSENSITIVE HTSH

    MDR report key: 4090993 · Received September 16, 2014

    Report

    Report Number
    8020879-2014-00009
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 18, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JLW
    PMA / PMN Number
    K042281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION THAT THE ACCESS HYPERSENSITIVE HTSH ASSAY WAS RETURNED FOR EVALUATION. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM AND DID NOT OBSERVE ANY FLUID LEAK. THE FSE REMOVED AND CLEANED THE WASH WHEEL AND VERIFIED THE CONDITION OF THE PERISTALTIC PUMP TUBING FOR THE ASPIRATE PROBES AND THE HYDRO DRAWER. THE FSE NOTED ASPIRATE PROBE A2 HAD A RUST-LIKE RESIDUE AT THE TIP AND PROACTIVELY REPLACED THE ASPIRATE PROBES. THE FSE COMPLETED SYSTEM CHECK AND PRECISION TEST. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. IN CONCLUSION, A DEFINITIVE CAUSE OF THE INCIDENT COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION. THIS MEDWATCH REPORT IS RELATED TO MDR 2122870-2014-00654.

    Description of Event or Problem · 1

    THE AFFILIATE STATED THE CUSTOMER REPORTED IMPRECISION ON FOUR REPLICATES ON THYROID-STIMULATING HORMONE (TSH) INVOLVING THE ACCESS HYPERSENSITIVE HTSH ASSAY USED IN CONJUNCTION WITH THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER STATED THE RESULTS WERE RELEASED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT IMPACT ASSOCIATED WITH THIS EVENT. THE CUSTOMER PERFORMED SYSTEM DIAGNOSTICS AND NOTICED WHITE POWDER ON THE ANALYTICAL WHEEL. THE CUSTOMER INDICATED QUALITY CONTROL (QC) WAS WITHIN SPECIFICATION PRIOR TO AND FOLLOWING THE EVENT WITH THE EXCEPTION OF LEVEL 1 QC, WHICH WAS OUT OF RANGE HIGH. INSPECTION OF CALIBRATION AND SYSTEM CHECK DATA REVEALED NO SYSTEM ISSUE. SERVICE WAS REQUESTED AND A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571280 ACCESS HYPERSENSITIVE HTSH RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW BECKMAN COULTER NA 426286

    Patients

    Seq Age Sex Outcome Treatment
    1