BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS SHBG

    MDR report key: 20304679 · Received September 25, 2024

    Report

    Report Number
    1823260-2024-02766
    Event Type
    Malfunction
    Date Received
    September 25, 2024
    Date of Event
    August 30, 2024
    Report Date
    October 14, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDZ
    UDI-DI
    04015630939305
    PMA / PMN Number
    K102814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE CUSTOMER'S COBAS 6000 E 601 MODULE IS (B)(6). THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION REVIEWED THE CALIBRATION DATA AND THE SIGNALS WERE SLIGHTLY HIGHER THAN EXPECTED. THE INVESTIGATION REVIEWED THE QC DATA AND THE RESULTS WERE WITHIN RANGE BEFORE THE PATIENT SAMPLE RUN. A GENERAL REAGENT PROBLEM WAS NOT PRESENT BECAUSE THE QCS BEFORE THE EVENT WERE WITHIN RANGE. BASED ON THE INFORMATION PROVIDED, THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS SHBG RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 6000 E 601 MODULE. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY AS THE REPORTER SUSPECTED THE INITIAL RESULT TO BE TOO LOW. THE INITIAL RESULT WAS 0.92 NMOL/L. THE FIRST REPEAT RESULT WAS 30.93 NMOL/L. THE SECOND REPEAT RESULT WAS 27.37 NMOL/L. THE REPEAT RESULTS WERE DEEMED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1199115 ELECSYS SHBG TESTOSTERONE TEST SYSTEM CDZ ROCHE DIAGNOSTICS 74103101 04015630939305

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male