BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TSH ASSAY

    MDR report key: 6521637 · Received April 26, 2017

    Report

    Report Number
    1823260-2017-00885
    Event Type
    Malfunction
    Date Received
    April 26, 2017
    Date of Event
    March 30, 2017
    Report Date
    May 30, 2017
    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

    THE PATIENT SAMPLE WAS SUBMITTED FOR INVESTIGATION. INITIAL INVESTIGATION OF THE SAMPLE CONFIRMED THE SAMPLE CONTAINED AN IMMUNOGLOBULIN THAT REACTS WITH THE FT4 AND FT3 REAGENTS WHICH AFFECTS THE SAMPLE RESULTS. THE TSH RESULT RECEIVED DURING THE INVESTIGATION WAS OUTSIDE OF THE REFERENCE RANGE. INVESTIGATION OF THE PATIENT SAMPLE IS ONGOING.

    Additional Manufacturer Narrative · 1

    THE PATIENT SAMPLE WAS INVESTIGATED FURTHER. THE CUSTOMER'S TSH, FT4 AND FT3 RESULTS WERE REPRODUCED. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS. THE MATHEMATICAL DIFFERENCES IN THE TSH RESULTS RELATE TO VARIANCES THAT MAY OCCUR IN THE UPPER MEASURING RANGE OF THE TSH ASSAY.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER QUESTIONED RESULTS FROM 1 PATIENT SAMPLE TESTED FOR ELECSYS TSH ASSAY(TSH), FREE THYROXINE (FT4) AND FT3 - FREE TRIIODOTHYRONINE (FT3). THE CUSTOMER PROVIDED THE PATIENT SAMPLE FOR INVESTIGATION. OF THE DATA PROVIDED, ERRONEOUS TSH, FT4 AND FT3 RESULTS WERE IDENTIFIED BETWEEN THE CUSTOMER'S E602 ANALYZER, A COBAS 6000 E 601 MODULE USED AT THE INVESTIGATION SITE AND A COBAS E 411 IMMUNOASSAY ANALYZER USED AT THE INVESTIGATION SITE. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL COVER TSH. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(4) FOR INFORMATION ON THE FT4 ERRONEOUS RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(4) FOR INFORMATION ON THE FT3 ERRONEOUS RESULTS. THERE WAS NO ALLEGATION AN ADVERSE EVENT OCCURRED. THE E601 MODULE SERIAL NUMBER WAS (B)(4). THE E411 ANALYZER SERIAL NUMBER WAS (B)(4). THE TSH REAGENT LOT NUMBER USED AT THE INVESTIGATION SITE WITH THE E601 MODULE WAS 189279 WITH AN EXPIRATION DATE OF (B)(4) 2017. THE TSH REAGENT LOT NUMBER USED AT THE INVESTIGATION SITE WITH THE E411 ANALYZER WAS 212491 WITH AN EXPIRATION DATE OF 05/31/2017. THE SERIAL NUMBER FOR THE CUSTOMER'S E602 ANALYZER IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306181 ELECSYS TSH ASSAY RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1