BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS VITAMIN D TOTAL III

    MDR report key: 23488025 · Received November 6, 2025

    Report

    Report Number
    1823260-2025-04532
    Event Type
    Malfunction
    Date Received
    November 6, 2025
    Date of Event
    October 14, 2025
    Report Date
    January 20, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MRG
    PMA / PMN Number
    K210901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYZER SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    SECTION D4, LOT NUMBER WAS UPDATED. SPECIFIC PATIENT RESULTS WERE PROVIDED. FOR THE RESULTS ON 01-APR-2025, REAGENT LOT 828391 WAS USED. FOR THE RESULTS ON 14-OCT-2025, REAGENT LOT 853684 WAS USED. ON 04-APR-2025: SAMPLE 1 RESULT WAS 110.80 NG/ML. SAMPLE 2 RESULT WAS 102.30 NG/ML. BOTH SAMPLES WERE REPEATED, AND SIMILAR RESULTS WERE OBTAINED. THE SPECIFIC RESULTS WERE NOT PROVIDED. ON 14-OCT-2025: SAMPLE 1 RESULT WAS > 120 NG/ML. SAMPLE 2 RESULT WAS 105.3 NG/ML. BOTH SAMPLES WERE REPEATED, AND SIMILAR RESULTS WERE OBTAINED. THE SPECIFIC RESULTS WERE NOT PROVIDED. ON 14-OCT-2025, THE SAMPLES WERE SENT TO ANOTHER LABORATORY AND TESTED ON AN E411 ANALYZER: SAMPLE 1 RESULT WAS 35.20 NG/ML. SAMPLE 2 RESULT WAS 28.60 NG/ML. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    SECTION D PRODUCT INFORMATION HAS BEEN UPDATED, AS WELL AS G1 MANUFACTURING SITE AND G4. THE REPEAT RESULTS WERE FROM ANOTHER LABORATORY AND WERE REPORTED. THE PROVIDED QC RESULTS WERE WITHIN THE SPECIFIED RANGES. BASED ON THE AVAILABLE DATA, A GENERAL REAGENT ISSUE COULD BE EXCLUDED. THE PATIENT SAMPLES WERE REQUESTED, BUT ARE NOT AVAILABLE FOR INVESTIGATION. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS VITAMIN D TOTAL II RESULTS FOR 2 PATIENT SAMPLES ON A COBAS E 411 ANALYZER. THE INITIAL RESULT OF BOTH SAMPLES WAS >100 NG/ML. BOTH SAMPLES WERE REPEATED AND BOTH GAVE SIMILAR RESULTS TO THE ONES OBTAINED IN THE INITIAL RUNS. THE SAMPLES WERE REPEATED AGAIN ON A DIFFERENT ANALYZER AND BOTH GAVE A RESULT OF APPROXIMATELY 30 NG/ML. THE EXACT SAMPLE RESULTS WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176023 ELECSYS VITAMIN D TOTAL III VITAMIN D TEST SYSTEM MRG ROCHE DIAGNOSTICS 853684

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male