BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TESTOSTERONE G2

    MDR report key: 7003096 · Received November 6, 2017

    Report

    Report Number
    1823260-2017-02537
    Event Type
    Malfunction
    Date Received
    November 6, 2017
    Date of Event
    October 3, 2017
    Report Date
    November 28, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDZ
    PMA / PMN Number
    K093421
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED AS NO SAMPLE MATERIAL WAS AVAILABLE FOR FURTHER INVESTIGATION. PER PRODUCT LABELING, THERE IS CROSS-REACTIVITY WITH NORGESTREL ( LEVONORGESTREL). SINCE THEY ALL HAVE A STEROID STRUCTURE, CROSS-REACTIVITY COULD BE POSSIBLE WITH THE CORTICOSTEROID AND THE CONTRACEPTIVE PILL. CROSS-REACTIVITY WITH TERBUTALINE WOULD NOT BE LIKELY. REVIEW OF THE PROVIDED CALIBRATION, QC, AND ANALYZER DATA DID NOT INDICATE ANY ISSUES WITH THE REAGENT OR INSTRUMENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE HIGH ELECSYS TESTOSTERONE II ASSAY RESULT FOR ONE PATIENT SAMPLE. THE RESULT FROM THE COBAS 8000 E 801 MODULE SERIAL NUMBER (B)(4) WAS 12.60 NMOL/L AND THE REPEAT RESULT ON (B)(6) 2017 WAS 11.90 NMOL/L. THE SAMPLE WAS SENT TO ANOTHER LABORATORY FOR TESTING BY LC-MS/MS AND THE TESTOSTERONE RESULT WAS 0.4 NMOL/L. THE RESULTS WERE REPORTED TO THE CLINICIAN. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER SUSPECTED THE MEDICATIONS TAKEN BY THE PATIENT WERE CAUSING INTERFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784676 TESTOSTERONE G2 RADIOIMMUNOASSAY, TESTOSTERONE CDZ ROCHE DIAGNOSTICS NA 23298000

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR