BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 3573208 · Received January 14, 2014

    Report

    Report Number
    1823260-2014-00287
    Event Type
    Malfunction
    Date Received
    January 14, 2014
    Date of Event
    December 13, 2013
    Report Date
    February 25, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE FOR THE ISSUE WITH TSH. THE CUSTOMER'S RESULT FOR TSH COULD NOT BE CONFIRMED AND NO INTERFERING FACTOR COULD BE IDENTIFIED. IT WAS NOTED THE RESULTS FOR THE ASSAYS USING A PREWASH WERE HIGHER THAN THE RESULTS OF THE ASSAYS WITHOUT THE PREWASH. THIS COULD HAVE POSSIBLY BEEN CAUSED BY A COMBINATION OF THE DETECTED STREPTAVIDIN INTERFERING FACTOR AND THE PREWASH STEP.

    Additional Manufacturer Narrative · 1

    AS PART OF THE INVESTIGATION, A SAMPLE FROM THE PATIENT WAS SUBMITTED FOR FURTHER TESTING. THE RESULTS INDICATED THE PRESENCE OF A STREPTAVIDIN INTERFERING FACTOR WHICH COULD CAUSE THE ELEVATED FT3 AND FT4 RESULTS. PRODUCT LABELING DOCUMENTS THIS INTERFERENCE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED. THE PATIENT WAS A MALE BORN IN 1942. THE PATIENT WAS NOT ADVERSELY AFFECTED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE THYROID RESULTS FOR ONE PATIENT. IT WAS UNCLEAR IF ANY OF THE RESULTS PROVIDED WERE GENERATED FROM THE SAME SAMPLE. ON (B)(6) 2013, THE RESULTS FROM THE ROCHE ANALYZER WERE: FREE TRIIODOTHYRONINE (FT3): 8.3 PG/ML, FREE THYROXINE (FT4): 30.6 PG/ML AND THYROTROPIN (TSH): 26.5 UI/ML FROM THE IMMULITE ANALYZER, THE RESULTS WERE: FT3: 3.2 PG/ML, FT4: 12.5 PG/ML INFORMATION CONCERNING WHICH RESULT WAS REPORTED OUTSIDE THE LABORATORY OR IF THE PATIENT WAS ADVERSELY AFFECTED WAS REQUESTED, BUT WAS NOT PROVIDED. THE FT3 REAGENT LOT NUMBER WAS 173844. THE FT4 REAGENT LOT NUMBER WAS 175155. THE TSH REAGENT LOT NUMBER WAS 174482. THE EXPIRATION DATES WERE REQUESTED, BUT WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37250 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1