BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TESTOSTERONE II ASSAY

    MDR report key: 20112606 · Received August 30, 2024

    Report

    Report Number
    1823260-2024-02526
    Event Type
    Malfunction
    Date Received
    August 30, 2024
    Date of Event
    August 3, 2024
    Report Date
    September 30, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDZ
    PMA / PMN Number
    K211685
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CALIBRATION AND QC WERE ACCEPTABLE. NO ISSUES WERE IDENTIFIED DURING A REVIEW OF THE ALARM TRACE DATA. THE FIELD SERVICE ENGINEER (FSE) VERIFIED ALL MECHANICAL AND FLUIDIC ADJUSTMENTS AND PERFORMED AN INSTRUMENT CHECK. ALL CHECKS PASSED AND NO INSTRUMENT ISSUES WERE IDENTIFIED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE E801 ANALYZER SERIAL NUMBER IS (B)(6).

    Description of Event or Problem · 0

    THE INITIAL REPORTER QUESTIONED LOW RESULTS FOR 15 PATIENT SAMPLES TESTED FOR ELECSYS TESTOSTERONE II ASSAY (TESTOSTERONE II) ON A COBAS E 801 ANALYTICAL UNIT. DISCREPANT RESULTS WERE PROVIDED FOR 3 PATIENT SAMPLES. PATIENT 1 INITIAL RESULT WAS 461 NG/DL. THE REPEAT RESULT WAS 748 NG/DL. PATIENT 2 INITIAL RESULT WAS <2.5 NG/DL WITH A DATA FLAG. THE REPEAT RESULT WAS 15.7 NG/DL. PATIENT 3 INITIAL RESULT WAS 47.1 NG/DL. THE REPEAT RESULT WAS 96.4 NG/DL. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THE DOCTOR QUESTIONED THEM. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847587 ELECSYS TESTOSTERONE II ASSAY TESTOSTERONE ASSAY CDZ ROCHE DIAGNOSTICS 75447801

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male