BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS VITAMIN D TOTAL III

    MDR report key: 23741510 · Received December 8, 2025

    Report

    Report Number
    1823260-2025-04984
    Event Type
    Malfunction
    Date Received
    December 8, 2025
    Date of Event
    November 8, 2025
    Report Date
    December 18, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MRG
    UDI-DI
    07613336172650
    PMA / PMN Number
    K210901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER PRODUCT LABELING, "6.00-120 NG/ML OR 15.0-300 NMOL/L (DEFINED BY THE LIMIT OF QUANTITATION (LOQ) AND THE MAXIMUM OF THE MASTER CURVE). VALUES BELOW THE LIMIT OF QUANTITATION ARE REPORTED AS < 6.00 NG/ML (< 15.0 NMOL/L). VALUES ABOVE THE MEASURING RANGE ARE REPORTED AS > 120 NG/ML (> 300 NMOL/L) OR UP TO 240 NG/ML (600 NMOL/L) FOR 2-FOLD DILUTED SAMPLES." "LOWER LIMITS OF MEASUREMENT. LIMIT OF BLANK, LIMIT OF DETECTION AND LIMIT OF QUANTITATION. LIMIT OF BLANK = 2.0 NG/ML (5.0 NMOL/L). LIMIT OF DETECTION = 3.0 NG/ML (7.5 NMOL/L). LIMIT OF QUANTITATION = 6.0 NG/ML (15.0 NMOL/L)". IN GENERAL, THE RESULTS MEASURED BY THE CUSTOMER ARE IN THE LOW MEASURING RANGE. IN THE LOW MEASURING RANGE, SLIGHT IMPRECISION COULD LEAD TO DISCREPANCIES BETWEEN THE MODULES. THE IMPRECISION IS POSSIBLY CAUSED BY CONTAMINATION OR ISSUES DURING THE PRE-ANALYTICAL PREPARATION. THE INVESTIGATION DETERMINED THAT A GENERAL REAGENT OR ANALYZER PROBLEM WAS NOT PRESENT BECAUSE THE QC PRIOR TO THE EVENT WAS WITHIN RANGES. THE INVESTIGATION ALSO DETERMINED THAT THERE WAS DUST PRESENT ON THE INSTRUMENT SURFACE, AND THERE WAS CRYSTALLIZATION AT THE PRO CELL AND CLEAN CELL NOZZLES.

    Additional Manufacturer Narrative · 0

    THE COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER IS (B)(6). THE CUSTOMER REPORTED EXPERIENCING INCONSISTENT CALIBRATION SIGNALS BUT WERE STILL IN THE EXPECTED RANGE. THE QC WAS WITHIN RANGE BEFORE THE SAMPLE MEASUREMENT ON (B)(6) 2025. THE QC WAS NOT IN RANGE ON (B)(6) 2025, BEFORE THE REPEAT MEASUREMENT. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS VITAMIN D TOTAL III RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT FOR TWO PATIENTS. PATIENT 1'S INITIAL RESULT WAS 6.18 NG/ML. THE REPEAT RESULT ON (B)(6) 2025 WAS 16.9 NG/ML. PATIENT 2'S INITIAL RESULT WAS 11.1 NG/ML. THE REPEAT RESULT ON (B)(6) 2025 WAS 20.7 NG/ML. THE SAMPLES WERE REPEATED WHEN THE CUSTOMER NOTICED THAT MULTIPLE RESULTS WERE LOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232857 ELECSYS VITAMIN D TOTAL III VITAMIN D TEST SYSTEM MRG ROCHE DIAGNOSTICS 868972 07613336172650

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male