BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION(R) CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2063375 · Received April 19, 2011

    Report

    Report Number
    2517506-2011-00071
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 22, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    JLW
    PMA / PMN Number
    K081074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE LIKELY CAUSE FOR THE FALSELY ELEVATED TSH RESULT IS HETEROPHILIC ANTIBODY INTERFERENCE. THE TSH DIMENSION(R) FLEX(R) REAGENT CARTRIDGE INSTRUCTIONS FOR USE CONTAINS THE STATEMENT: "PATIENT SAMPLES MAY CONTAIN HETEROPHILIC ANTIBODIES THAT COULD REACT IN IMMUNOASSAYS TO GIVE FALSELY ELEVATED OR DEPRESSED RESULTS. THIS ASSAY HAS BEEN DESIGNED TO MINIMIZE INTERFERENCE FROM HETEROPHILIC ANTIBODIES. NEVERTHELESS, COMPLETE ELIMINATION OF THIS INTERFERENCE FROM ALL PATIENT SPECIMENS CANNOT BE GUARANTEED." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSELY ELEVATED THYROID STIMULATING HORMONE (TSH) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS ALTERED ON THE BASIS OF THE ELEVATED RESULT. A THYROID MEDICATION (SYNTHROID) WAS ADMINISTERED AND A NEW SAMPLE YIELDED A SIMILARLY ELEVATED RESULTS WHICH WERE QUESTIONED BY THE PHYSICIAN. THE PATIENT SAMPLE WAS THEN TESTED ON AN ALTERNATE INSTRUMENT SYSTEM AND LOWER RESULTS WITHIN THE NORMAL RANGE WERE OBTAINED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED TSH RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION(R) CLINICAL CHEMISTRY SYSTEM THYROID STIMULATING HORMONE FLEX® REAGENT CARTRIDGE JLW SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW

    Patients

    Seq Age Sex Outcome Treatment
    1