BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FT3 - FREE TRIIODOTHYRONINE

    MDR report key: 3781573 · Received April 30, 2014

    Report

    Report Number
    1823260-2014-03109
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    January 14, 2014
    Report Date
    May 29, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDP
    PMA / PMN Number
    K963127
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS PROVIDED. THE DISCREPANT RESULTS WERE REPORTED OUTSIDE THE LABORATORY.

    Additional Manufacturer Narrative · 1

    ONE PATIENT SAMPLE WAS RETURNED FOR INVESTIGATION. THE CUSTOMER'S HIGH PATIENT RESULTS WERE REPRODUCED. AN INTERFERING FACTOR TO STREPTAVIDIN WAS IDENTIFIED FOR FT3 AND FT4. THIS INTERFERENCE IS COVERED IN THE PRODUCT LABELING. OTHER REAGENT INVOLVED IN THE COMPLAINT: BRAND NAME: FT4, FREE THYROXINE COMMON DEVICE NAME: RADIOIMMUNOASSAY, FREE THYROXINE. MANUFACTURER INFORMATION: FREE TRIIODOTHYRONINE, CATALOG NUMBER: 06437281190, LOT NUMBER: ASKU, EXPIRATION DATE: ASKU. MANUFACTURING SITE: - FREE TRIIODOTHYRONINE. PMA/510(K)#: K961489.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE FREE TRIIODOTHYRONINE (FT3), FREE THYROXINE (FT4), AND ANTIBODIES TO THYROID PEROXIDASE (A- TPO) RESULTS FOR ONE PATIENT ON THEIR E601 ANALYZER. THE CUSTOMER HAD THE PATIENT'S SAMPLE REPEATED IN ANOTHER LABORATORY WITH A DIFFERENT METHOD. THE UNITS OF MEASURE WERE REQUESTED BUT NOT PROVIDED. THE PATIENT'S INITIAL FT3 RESULT WAS 12.7. THE REPEAT RESULT WAS 7.0. THE PATIENT'S INITIAL FT4 RESULT WAS 39.8. THE REPEAT RESULT WAS 13.8. THE PATIENT'S INITIAL A-TPO RESULT WAS 91.2. THE REPEAT RESULT WAS <10. INFORMATION ON WHETHER THE DISCREPANT RESULTS WERE REPORTED OUTSIDE THE LABORATORY WAS REQUESTED BUT NOT PROVIDED. THE PATIENT HAD AN X-RAY TO PREDICT HER FINAL HEIGHT. THE PATIENT'S INITIAL LABORATORY RESULTS IN COMBINATION WITH HER BEING A TALL GIRL MADE THE DOCTOR SUSPECT A PITUITARY DISORDER. THIS HAS NOW BEEN RULED OUT. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE FT3 REAGENT LOT NUMBER WAS 173844. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED. THE FT4 REAGENT LOT NUMBER WAS 175155. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED. THE A-TPO REAGENT LOT NUMBER WAS 173118. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260444 FT3 - FREE TRIIODOTHYRONINE RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE CDP ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 012 YR