BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TESTOSTERONE II ASSAY

    MDR report key: 11869466 · Received May 24, 2021

    Report

    Report Number
    1823260-2021-01526
    Event Type
    Malfunction
    Date Received
    May 24, 2021
    Date of Event
    April 22, 2021
    Report Date
    July 19, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDZ
    PMA / PMN Number
    K093421
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    FURTHER INVESTIGATIONS OF THE SAMPLES DETERMINED THEY DO NOT CONTAIN INTERFERING FACTOR AGAINST THE RUTHENIUM COMPONENT OF THE TESTOSTERONE ASSAY. A BIOTIN INTERFERENCE COULD ALSO BE EXCLUDED. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. A GENERAL REAGENT ISSUE CAN LIKELY BE EXCLUDED. MEDWATCH FIELD D4. HAS BEEN UPDATED.

    Additional Manufacturer Narrative · 0

    SAMPLES FROM THE PATIENT WERE PROVIDED FOR INVESTIGATION. THE TESTOSTERONE MEASUREMENTS OF THE SAMPLES WERE FOUND TO BE HIGHER THAN THE REFERENCE RANGE FOR PEOPLE YOUNGER THAN 18 YEARS. FURTHER INVESTIGATIONS OF THE SAMPLES DETERMINED THEY DO NOT CONTAIN INTERFERING FACTOR AGAINST THE STREPTAVIDIN COMPONENT OF THE TESTOSTERONE ASSAY. INVESTIGATIONS ARE ONGOING.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). UDI NUMBER = (B)(4).

    Description of Event or Problem · 1

    THE INITIAL REPORTER STATED THEY RECEIVED A DISCREPANT RESULT FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS TESTOSTERONE II ASSAY ON AN UNKNOWN ROCHE ANALYZER. THE RESULTS DID NOT COMPARE TO RESULTS OBTAINED WITH THE LCMSMS METHOD. THE SAMPLE RESULTED WITH A TESTOSTERONE VALUE OF 5.7 NMOL/L AND REPEATED AS 4.9 NMOL/L WHEN TESTED USING THE ELECSYS TESTOSTERONE ASSAY. THE SAMPLE WAS TESTED USING THE LCMSMS METHOD, RESULTING IN A VALUE OF 0.32 NMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765689 ELECSYS TESTOSTERONE II ASSAY RADIOIMMUNOASSAY, TESTOSTERONE CDZ ROCHE DIAGNOSTICS NA 472593

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR