BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TESTOSTERONE G2

    MDR report key: 7116446 · Received December 14, 2017

    Report

    Report Number
    1823260-2017-02917
    Event Type
    Malfunction
    Date Received
    December 14, 2017
    Date of Event
    November 21, 2017
    Report Date
    December 20, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDZ
    PMA / PMN Number
    K093421
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. THE PATIENT HAS FMS. GESTRINONE IS SIMILAR TO 19-NORETHISTERONE, WHICH CROSS-REACTS WITH THE TESTOSTERONE II ASSAY AT ~6%. IT IS EXPECTED GESTRINONE WOULD ALSO EXHIBIT SOME CROSS-REACTIVITY. IT IS GENERALLY RECOMMENDED NOT TO MEASURE STEROID CONCENTRATIONS IN PATIENT UNDER TREATMENT WITH STEROIDS. IF STEROIDS MUST BE MEASURED THE RESULTS MUST BE INTERPRETED WITH CAUTION. THE INVESTIGATION DETERMINED THE DIFFERENCE IN THE RESULTS FROM THE TWO METHODS WAS MOST LIKELY CAUSED BY A CROSS-REACTIVITY OF GESTRINONE WITH THE ELECSYS TESTOSTERONE II WHICH APPEARED TO NOT AFFECT THE CLIA ASSAY. A TRUE PHYSIOLOGICAL CHANGE IN HORMONE CONCENTRATION COULD NOT BE EXCLUDED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE HIGH ELECSYS TESTOSTERONE II ASSAY RESULTS FOR ONE PATIENT SAMPLE FROM COBAS E 411 IMMUNOASSAY ANALYZER SERIAL NUMBER (B)(4). SAMPLE 1 WAS DRAWN (B)(6) 2017 AND THE INITIAL RESULT ON (B)(6) 2017 WAS 531.60 NG/DL. THIS RESULT WAS REPORTED TO THE PATIENT WHO TOLD THE LABORATORY SHE DID NOT HAVE A PREVIOUS HIGH RESULT. ON (B)(6) 2017, THE REPEAT RESULT ON THE SAME ANALYZER WAS 472.70 NG/DL. AN ALIQUOT WAS SENT TO ANOTHER LABORATORY AND THE RESULT WAS 35 NG/DL (CLIA METHOD). A SECOND SAMPLE DRAWN FROM THE PATIENT ON (B)(6) 2017 WAS TESTED AT ANOTHER LABORATORY (UNKNOWN METHOD) AND THE RESULT WAS 60 NG/DL. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE FIELD SERVICE REPRESENTATIVE BELIEVED THERE WAS AN INTERFERENCE RELATED TO THE METHODOLOGY AND SUPPLEMENTS TAKEN BY THE PATIENT. REVIEW OF THE PROVIDED CALIBRATION AND QC DATA DID NOT SUGGEST A REAGENT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899284 TESTOSTERONE G2 RADIOIMMUNOASSAY, TESTOSTERONE CDZ ROCHE DIAGNOSTICS NA 232994

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR