BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSH, THYROTROPIN

    MDR report key: 3736597 · Received April 9, 2014

    Report

    Report Number
    1823260-2014-02539
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    April 2, 2014
    Report Date
    July 21, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THREE PATIENT SAMPLES WERE RETURNED FOR INVESTIGATION. A INTERFERING FACTOR TO STREPTAVIDIN WAS IDENTIFIED. THIS INTERFERENCE WAS COVERED BY THE PRODUCT LABELING. BRAND NAME: FT3 - FREE TRIIODOTHYRONINE. COMMON DEVICE NAME: RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE. PRODUCT CODE: CDP. CATALOG NUMBER: 06437206190, LOT NUMBER: ASKU, EXPIRATION DATE: ASKU. MANUFACTURING SITE: SAME AS FOR TSH, THYROTROPIN. THE PMA/510(K)#: K963127. BRAND NAME: FT4, FREE THYROXINE. COMMON DEVICE NAME: RADIOIMMUNOASSAY, FREE THYROXINE. PRODUCT CODE: CEC. MANUFACTURER INFORMATION: SAME AS FOR TSH, THYROTROPIN. CATALOG NUMBER: 06437281190, LOT NUMBER: ASKU, EXPIRATION DATE: ASKU. THE PMA/510(K)#: K961489.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). THE SPECIFIC PART NUMBER INVOLVED IN THIS EVENT WAS REQUESTED BUT NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER. THE DATE OF THIS EVENT, WAS (B)(6) 2014. THE PATIENT'S TSH RESULT FROM THE ABBOTT ANALYZER WAS 1.064 UIU/ML. THE PATIENT'S FT4 RESULT FROM THE ABBOTT ANALYZER WAS 1.34 NG/DL. THE PATIENT'S FT3 RESULT WAS 3.07 PG/ML. THE CUSTOMER ALSO PROVIDED THE FOLLOWING RESULTS FOR THE PATIENT. INFORMATION ON WHETHER RESULTS WERE FROM THE SAME SAMPLE WAS REQUESTED BUT NOT PROVIDED. THE PATIENT HAD AN FT3 RESULT OF 7.6 PG/ML. THE PATIENT HAD AN FT4 RESULT OF 2.3 NG/DL. THE PATIENT HAD A TSH RESULT OF 0.22 UIU/ML.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE FREE TRIIODOTHYRONINE (FT3), FREE THYROXINE (FT4), AND THYROTROPIN (TSH) RESULTS FOR ONE PATIENT ON THEIR E602 ANALYZER. A PHYSICIAN QUESTIONED THE PATIENT'S THYROID RESULTS FROM THE E602 ANALYZER. THE CUSTOMER SENT THE PATIENT'S SAMPLE TO A COMMERCIAL LABORATORY AND THE SAMPLE WAS TESTED ON AN ARCHITECT ANALYZER. THE PATIENT'S FT3 RESULT FROM THE E602 ANALYZER WAS 7.9 PG/ML. THE FT3 RESULT FROM THE ARCHITECT ANALYZER WAS 3.1 PG/ML. THE PATIENT'S FT4 RESULT FROM THE E602 ANALYZER WAS 2.6 NG/DL. THE FT4 RESULT FROM THE ARCHITECT ANALYZER WAS 1.3 NG/DL. THE PATIENT'S TSH RESULT FROM THE E602 ANALYZER WAS 0.2 UIU/ML. THE TSH RESULT FROM THE ARCHITECT ANALYZER WAS 1.06 UIU/ML. THERE WERE NO DEATHS, INJURIES, ILLNESSES, OR DETERIORATIONS IN HEALTH ASSOCIATED WITH THE ERRONEOUS RESULTS. INFORMATION ON WHETHER THE PATIENT WAS HARMED BY ANY ACTION TAKEN WAS REQUESTED BUT NOT PROVIDED. THE FT3, FT4, AND TSH REAGENT LOT NUMBERS AND EXPIRATION DATES WERE REQUESTED BUT NOT PROVIDED. THE SPECIFIC DATE OF THIS EVENT WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215733 TSH, THYROTROPIN RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 ETIZOLAM| TRIAZOLAM| EPERISONE| AMLODIPINE| TOCOPHEROL