BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS FT3 III

    MDR report key: 7392336 · Received April 3, 2018

    Report

    Report Number
    1823260-2018-01021
    Event Type
    Malfunction
    Date Received
    April 3, 2018
    Date of Event
    March 5, 2018
    Report Date
    May 8, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDP
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLES (B)(6) WERE PROVIDED FOR INVESTIGATION. INVESTIGATIONS OF SAMPLE (B)(6) DETERMINED THAT IT CONTAINS AN INTERFERENT TO A COMPONENT OF THE FT3 ASSAY. THIS LIMITATION IS COVERED IN PRODUCT LABELING. NO INTERFERING FACTOR COULD BE FOUND IN SAMPLE (B)(6). BASED ON MEASURED RESULTS FROM THIS SAMPLE, NO PRODUCT PROBLEM WAS FOUND.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR FIVE PATIENT SAMPLES TESTED FOR ELECSYS FT3 III (FT3), THE ELECSYS FT4 II ASSAY (FT4), AND THE ELECSYS TSH ASSAY (TSH) ON A COBAS 8000 E 801 MODULE (E801). IT WAS ASKED, BUT IT IS NOT KNOWN IF ANY ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. PATIENT IDENTIFIERS FOR INFORMATION RELATED TO EACH AFFECTED ASSAY: PT-22234 = FT3, PT-22235 = FT4, PT-22236 = TSH. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE ERRONEOUS VALUES ARE HIGHLIGHTED IN YELLOW. THE SAMPLE WERE INITIALLY TESTED AT THE CUSTOMER SITE ON THE E801 ANALYZER. THE SAMPLE WAS REPEATED ON A CENTAUR ANALYZER. THE SAMPLE WAS ALSO PROVIDED FOR INVESTIGATION, WHERE IT WAS TESTED ON A SECOND E801 ANALYZER, A COBAS 8000 E 602 MODULE (E602), AND A COBAS E 411 IMMUNOASSAY ANALYZER (E411). NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENTS. THE SERIAL NUMBER OF THE E801 ANALYZER USED AT THE CUSTOMER SITE WAS ASKED FOR, BUT NOT PROVIDED. THE E801 ANALYZER USED FOR INVESTIGATION WAS SERIAL NUMBER (B)(4). FT3 REAGENT LOT NUMBER 232740, WITH AN EXPIRATION DATE OF 31-JUL-2018 WAS USED ON THIS ANALYZER. THE E602 ANALYZER USED FOR INVESTIGATION WAS SERIAL NUMBER (B)(4). FT3 REAGENT LOT NUMBER 277945, WITH AN EXPIRATION DATE OF 30-SEP-2018 WAS USED ON THIS ANALYZER. THE E411 ANALYZER USED FOR INVESTIGATION WAS SERIAL NUMBER (B)(4). FT3 REAGENT LOT NUMBER 277945, WITH AN EXPIRATION DATE OF 30-SEP-2018 WAS USED ON THIS ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235249 ELECSYS FT3 III RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE CDP ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1