BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 350 CHEMISTRY SYSTEM

    MDR report key: 24271063 · Received February 5, 2026

    Report

    Report Number
    1319681-2026-00003
    Event Type
    Malfunction
    Date Received
    February 5, 2026
    Date of Event
    January 8, 2026
    Report Date
    February 4, 2026
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    UDI-DI
    10758750002054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT A HIGHER THAN EXPECTED VITROS SODIUM (NA+) RESULT WAS OBTAINED FROM A SINGLE LEVEL OF A NON-VITROS THERMOFISHER MAS CONTROL (LOT OCR2608) USING VITROS NA+ SLIDE LOT 4203-1176-6973 ON A VITROS 350 CHEMISTRY SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT IS A SUBOPTIMAL CALIBRATION DUE TO USER ERROR WITH CALIBRATOR KIT LOT SELECTION ON THE VITROS ANALYZER. THE CALIBRATOR KIT THAT THE CUSTOMER WAS USING (CAL KIT 2, LOT 0214) WAS NOT THE CALIBRATOR KIT THAT THE VITROS 350 CHEMISTRY SYSTEM WAS CONFIGURED FOR (CAL KIT 2, LOT 0293) AT THE TIME OF THE CALIBRATION EVENTS. THE ORTHO TECHNICAL SOLUTIONS CENTER (TSC) ASSISTED THE CUSTOMER WITH CHANGING THEIR VITROS CAL KIT LOT CONFIGURATION TO THE CORRECT CAL KIT 2 LOT NUMBER. THE CUSTOMER RECALIBRATED THE VITROS NA+ ASSAY. POST CALIBRATION QC RESULTS WERE SLIGHTLY OUTSIDE THE PACKAGE INSERT RANGE BUT SHOWED SUBSTANTIALLY LESS BIAS THAN THE ELEVATED VITROS NA+ RESULTS OBSERVED ON (B)(6) 2026. IN FOLLOW UP, THE CUSTOMER REPORTED ACCEPTABLE NA+ PERFORMANCE BUT PROVIDED NO DATA UPON REQUEST.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER THAN EXPECTED VITROS SODIUM (NA+) RESULT WAS OBTAINED FROM A SINGLE LEVEL OF A NON-VITROS THERMOFISHER MAS CONTROL (LOT OCR2608) USING VITROS NA+ SLIDE LOT 4203-1176-6973 ON A VITROS 350 CHEMISTRY SYSTEM. MAS OCR2608 LEVEL 1 RESULT OF 140.5 MMOL/L VS. THE EXPECTED RESULT OF 120.5 MMOL/L THE HIGHER THAN EXPECTED RESULTS WERE OBTAINED FROM A NON-PATIENT QUALITY CONTROL SAMPLE, HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WERE NOT OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WERE NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 613239.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333366 VITROS 350 CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS, INC. 10758750002054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown