BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSH, THYROTROPIN

    MDR report key: 3821494 · Received May 20, 2014

    Report

    Report Number
    1823260-2014-03561
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    May 6, 2014
    Report Date
    June 12, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K961491
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED A BIRTH DATE OF (B)(6) 2014, AND A PATIENT AGE OF (B)(6). CLARIFICATION WAS REQUESTED BUT NOT PROVIDED. DATE OF EVENT, SHOULD BE (B)(6) 2014. DATE RECEIVED BY MANUFACTURER, SHOULD BE (B)(4) 2014. ONE SAMPLE WAS RETURNED FOR INVESTIGATION. AN INTERFERING FACTOR TO STREPTAVIDIN WAS IDENTIFIED IN THE INVESTIGATED SAMPLE. THIS INTERFERENCE IS COVERED IN THE PACKAGE INSERT. TSH REAGENT. OTHER REAGENT INVOLVED IN THIS EVENT: BRAND NAME: FT4, FREE THYROXINE. COMMON DEVICE NAME: RADIOIMMUNOASSAY, FREE THYROXINE. MANUFACTURER INFORMATION: SAME AS FOR TSH, THYROTROPIN. CATALOG NUMBER: 06437281190, LOT NUMBER: 177593, EXPIRATION DATE: ASKU. MANUFACTURING SITE: SAME AS FOR TSH, THYROTROPIN. PMA/510(K)#: K961489.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE FREE THYROXINE (FT4) AND THYROTROPIN (TSH) RESULTS FOR ONE PATIENT ON THEIR E601 ANALYZER. THE SPECIFIC DATE OF THIS EVENT WAS REQUESTED BUT NOT PROVIDED. THE PATIENT INITIAL FT4 RESULT WAS 32.6 NG/L AND TSH RESULT WAS 1.15 MIU/L. THE CUSTOMER STATED THE SAMPLE WAS REPEATED ON A DIMENSION VISTA ANALYZER WHERE THEY FOUND NORMAL VALUES. THE REPEAT FT4 RESULT WAS 13.3 PMOL/L (10.33 NG/L) AND REPEAT TSH RESULT WAS 1.77 MIU/L. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE DOCTOR WAS CONTACTED THE SAME DAY WITH THE MESSAGE "POSSIBLE INTERFERENCE." THE PATIENT WAS NOT ADVERSELY AFFECTED BY THIS EVENT. THE FT4 REAGENT LOT NUMBER WAS 177593. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED. THE TSH REAGENT LOT NUMBER WAS 176496. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299483 TSH, THYROTROPIN RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ROCHE DIAGNOSTICS NA 176496

    Patients

    Seq Age Sex Outcome Treatment
    1 NASONEX| AERIUS