BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2

    MDR report key: 24331933 · Received February 13, 2026

    Report

    Report Number
    1319808-2026-00006
    Event Type
    Malfunction
    Date Received
    February 13, 2026
    Date of Event
    January 18, 2026
    Report Date
    February 12, 2026
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JIX
    UDI-DI
    10758750009503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS SODIUM (NA+) RESULTS WERE OBTAINED FROM A SINGLE NON-VITROS BIORAD LEVEL 1 QUALITY CONTROL FLUID, LOT: 93030, USING VITROS NA+ SLIDES ON A VITROS 5600 INTEGRATED SYSTEM. THE MOST LIKELY CAUSE OF THE SUBOPTIMAL CALIBRATIONS COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. THE EVENT WAS ISOLATED TO TWO CALIBRATION EVENTS PERFORMED ON 18 JANUARY 2026 (CALIBRATION CURVES 18331 AND 18337). THE CALIBRATIONS WERE SUBOPTIMAL WHEN COMPARED TO THE CALIBRATION RESPONSES AND PARAMETERS GENERATED WHEN CALIBRATOR KIT 2, LOT: 0224 WAS RELEASED. THE VITROS CALIBRATION KIT IN USE FOR BOTH CALIBRATION EVENTS WAS VITROS CAL KIT 224. NO INFORMATION WAS PROVIDED CONCERNING THE TYPE OF PIPETTE USED FOR RECONSTITUTION OR PRE-ANALYTICAL SAMPLE HANDLING OR STORAGE OF THE CALIBRATOR KIT 2, LOT: 0224 FLUIDS. THEREFORE, RECONSTITUTION USING AN INACCURATE PIPETTE OR IMPROPER PRE-ANALYTICAL SAMPLE HANDLING OR STORAGE OF THE CALIBRATOR KIT 2, LOT: 0224 FLUIDS CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. ACCEPTABLE VITROS NA+ PERFORMANCE WAS OBSERVED AFTER A CALIBRATION EVENT WAS PERFORMED USING AN ALTERNATE LOT OF CALIBRATOR FLUIDS, CALIBRATOR KIT 2, LOT: 0235. THE INVESTIGATION FOUND NO INDICATION THE VITROS 5600 INTEGRATED SYSTEM OR VITROS NA+ SLIDE LOT: 4202-1174-7380 CONTRIBUTED TO THE EVENT. HISTORICAL QC WAS ACCEPTABLE PRIOR TO THE FIRST 18 JAN 2026 CALIBRATION EVENT. ADDITIONALLY, CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC PERFORMANCE ISSUE WITH VITROS NA+ SLIDE LOT: 4202-1174-7380.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS SODIUM (NA+) RESULTS WERE OBTAINED FROM A SINGLE NON-VITROS BIORAD LEVEL 1 QUALITY CONTROL FLUID, LOT: 93030, USING VITROS NA+ SLIDES ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LEVEL 1 NA+ RESULTS OF 137.1 AND 140.1MMOL/L VS. THE EXPECTED RESULT OF 123.1 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE AFFECTED SAMPLES WERE NON-PATIENT QUALITY CONTROL SAMPLES. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO MDRS FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237441 VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 IN-VITRO DIAGNOSTICS JIX ORTHO-CLINICAL DIAGNOSTICS, INC. 0224 10758750009503

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown