BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSH, THYROTROPIN

    MDR report key: 4243835 · Received November 11, 2014

    Report

    Report Number
    1823260-2014-08779
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 8, 2014
    Report Date
    December 2, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K961491
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. FOR TSH, FT3, AND FT4, CALIBRATIONS ARE OK AND CONTROLS WERE WITHIN SPECIFICATIONS. FOR BOTH SAMPLES, THE RESULTS GENERATED AT THE CUSTOMER SITE, AT THE INVESTIGATION SITE, AND WITH THE CENTAUR ANALYZER ARE SIMILAR WITH RESPECT TO THE NORMAL REFERENCE RANGES OF THE RESPECTIVE ASSAYS. THE DIFFERENCE BETWEEN THE ROCHE AND CENTAUR ANALYZERS MOST LIKELY RELATES TO DIFFERENCES IN THE OVERALL SETUP OF THE ASSAYS, TYPE OF ANTIBODIES USED, AND STANDARDIZATION CONCEPTS AND METHODS. DIFFERENCES IN SAMPLE HANDLING COULD NOT BE EXCLUDED. A GENERAL REAGENT ISSUE CAN MOST LIKELY BE EXCLUDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY ASSUMED THAT FOUR OF THEIR PATIENTS HAD SYNDROME OF INAPPROPRIATE SECRETION FOR THYROTROPIN (TSH) - SITSH. THE CUSTOMER ASKED IF TWO OF THE PATIENT SAMPLES COULD BE INVESTIGATED IN ORDER TO IDENTIFY IF THEY ARE SITSH OR IF THEY HAVE A NONSPECIFIC REACTION. THE TWO PATIENT SAMPLES WERE PROVIDED FOR INVESTIGATION. DURING THE INVESTIGATION, ONE OF THE PATIENT SAMPLES WAS FOUND TO HAVE AN ERRONEOUS TSH RESULT. THE SAMPLE WAS MEASURED AT THE CUSTOMER SITE ON AN E601 ANALYZER ON (B)(6) 2014 AND RESULTED AS 2.75 UIU/ML. IT WAS ASKED, BUT IT IS NOT KNOWN IF THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS PROVIDED FOR INVESTIGATION, WHERE IT WAS TESTED ON AN E602 ANALYZER ON (B)(4) 2014 AND RESULTED AS 2.94 UIU/ML. DURING INVESTIGATION, THE SAMPLE WAS ALSO TESTED ON A CENTAUR ANALYZER ON (B)(4) 2014 AND RESULTED AS 2.0 UIU/ML. IT WAS ASKED, BUT IT IS NOT KNOWN WHICH RESULT CORRESPONDS TO THE PATIENT'S CONDITION. THE INVESTIGATION RESULTS WERE PROVIDED TO THE CUSTOMER. THERE WERE NO DEATHS ASSOCIATED WITH THE EVENT. IT WAS ASKED, BUT IT IS NOT KNOWN IF ANY PATIENTS WERE ADVERSELY AFFECTED. NO ADVERSE EVENTS WERE ALLEGED. THE SERIAL NUMBER OF THE E601 ANALYZER AT THE CUSTOMER SITE WAS ASKED FOR, BUT NOT PROVIDED. THE SERIAL NUMBER OF THE E602 MODULE AT THE INVESTIGATION SITE IS (B)(4). FOR THE INVESTIGATION, IT WAS CONCLUDED THAT THE PROBABILITY OF A NON- SPECIFIC REACTION CAN BE CONSIDERED LOW BASED ON THE SAMPLE MEASUREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725799 TSH, THYROTROPIN RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ROCHE DIAGNOSTICS NA 178605

    Patients

    Seq Age Sex Outcome Treatment
    1