BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSH, THYROTROPIN

    MDR report key: 3695879 · Received March 24, 2014

    Report

    Report Number
    1823260-2014-02047
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    March 6, 2014
    Report Date
    April 22, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K961491
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A SAMPLE FROM THE PATIENT WAS SUBMITTED FOR FURTHER INVESTIGATION AND THE CUSTOMER'S RESULTS WERE CONFIRMED. AN INTERFERING FACTOR AGAINST THE RUTHENIUM-LABELED DETECTION ANTIBODY OF THE ASSAYS WAS FOUND TO BE CONTAINED IN THE SAMPLE. PRODUCT LABELING DOCUMENTS THIS INTERFERENCE. OTHER REAGENT(S) INVOLVED IN THE COMPLAINT: BRAND NAME: FT3 - FREE TRIIODOTHYRONINE. COMMON DEVICE NAME: RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE PRODUCT CODE: CDP. MANUFACTURER INFORMATION: SAME AS FOR TSH, THYROTROPIN. CATALOG NUMBER: ASKU. LOT NUMBER: ASKU. EXPIRATION DATE: ASKU. MANUFACTURING SITE: SAME AS FOR TSH, THYROTROPIN. : PMA/510(K)#: K963127. BRAND NAME: FT4, FREE THYROXINE. COMMON DEVICE NAME: RADIOIMMUNOASSAY, FREE THYROXINE. MANUFACTURER INFORMATION: SAME AS FOR TSH, THYROTROPIN .CATALOG NUMBER: ASKU. LOT NUMBER: ASKU. EXPIRATION DATE: ASKU. MANUFACTURING SITE: SAME AS FOR TSH, THYROTROPIN. PMA/510(K)#: K961489.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE THYROTROPIN (TSH), FREE TRIIODOTHYRONINE (FT3) AND FREE THYROXINE (FT4) RESULTS FOR ONE PATIENT SAMPLE. THE INITIAL RESULTS WERE: TSH: 9.80 UIU/ML FT3: 3.76 PG/ML FT4: 2.08 NG/DL ON (B)(6) 2014, THE SAMPLE WAS REPEATED ON A BECKMAN UNICELL DXL 800 AT ANOTHER LABORATORY AND THE RESULTS WERE: TSH: 0.03 UIU/ML TWICE FT3: 5.35 PMOL/L (3.48 PG/ML) FT4: 19.87 PMOL/L (1.54 NG/DL) THE SAMPLE WAS ALSO REPEATED ON A CENTAUR ANALYZER AT ANOTHER LABORATORY AND THE RESULTS WERE: TSH: 0.01 UIU/ML FT3: 3.84 PMOL/L (2.49 PG/ML) FT4: 1.91 NG/DL ON (B)(6) 2014, THE SAMPLE WAS REPEATED ON THE ANALYTICAL E MODULE AND THE TSH RESULT WAS 9.94 UIU/ML. THE INITIAL AND LATER LOW RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE TSH REAGENT LOT NUMBER WAS 175157. THE EXPIRATION DATE WAS REQUESTED, BUT WAS NOT PROVIDED. THE FT3 AND FT4 REAGENT LOT NUMBERS AND EXPIRATION DATES WERE REQUESTED, BUT WERE NO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171449 TSH, THYROTROPIN RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ROCHE DIAGNOSTICS NA 175157

    Patients

    Seq Age Sex Outcome Treatment
    1 043 YR