BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREE T3

    MDR report key: 1900702 · Received November 16, 2010

    Report

    Report Number
    1823260-2010-06771
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    October 19, 2010
    Report Date
    January 4, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDP
    PMA / PMN Number
    K963127
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NEW ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2010: THE PATIENT SAMPLE WAS DRAWN ON (B)(6) 2010. IT IS UNCLEAR IF THE RESULTS GENERATED WERE FROM THE SAME SAMPLE, THE CUSTOMER WOULD NOT PROVIDE THAT INFORMATION. THE ELECSYS FT3 RESULT WAS >32.55 PG/ML. THE ABBOTT ANALYZER USED FOR TESTING WAS AN ABBOTT ARCHITECT. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. PATIENTS WERE NOT HARMED DUE TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE SAMPLE REVEALED AN INTERFERING FACTOR TO THE IDIOTYPE OF THE ASSAY ANTIBODY WAS PRESENT IN THE PATIENT SAMPLE. THE INTERFERING FACTOR MIGHT HAVE CAUSED THE HIGH FREE T3 RESULTS OBSERVED BY THE CUSTOMER. THIS IS ADDRESSED IN PRODUCT LABELING. THE FREE T3 PACKAGE INSERT DOCUMENTS, "IN RARE CASES, INTERFERENCE DUE TO EXTREMELY HIGH TITERS OF ANTIBODIES TO ANALYTE-SPECIFIC ANTIBODIES, STREPTAVIDIN OR RUTHENIUM CAN OCCUR". THE ELECSYS RESULT WAS NOT USED FOR CLINICAL USE.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE FREE TRIIODOTHYRONINE (FT3), GENERATION II, RESULTS FOR ONE PATIENT SAMPLE. THE SAMPLE WAS TESTED USING THE ELECSYS REAGENT AND USING AN ABBOTT REAGENT. THE ROCHE ANALYZER (AND SERIAL NUMBER) INVOLVED IN THIS EVENT IS UNCLEAR AT THIS TIME. INFORMATION REGARDING THE SPECIFIC ABBOTT ANALYZER USED WAS NOT PROVIDED. THE ELECSYS FT3 RESULT WAS <32.6 PG/ML. THE ABBOTT FT3 RESULT WAS 3.77 PG/ML. THE ELECSYS TRIIODOTHYRONINE (T3) RESULT WAS 0.70 NG/ML. NO ADVERSE EVENT HAS BEEN ALLEGED REGARDING THE DISCREPANCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREE T3 RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE CDP ROCHE DIAGNOSTICS NA 156811

    Patients

    Seq Age Sex Outcome Treatment
    1