BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2

    MDR report key: 25162988 · Received May 13, 2026

    Report

    Report Number
    1319808-2026-00023
    Event Type
    Malfunction
    Date Received
    May 13, 2026
    Date of Event
    April 17, 2026
    Report Date
    May 13, 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+) SLIDE LOT 4213-1185-0237 AND VITROS POTASSIUM (K+) SLIDE LOT 4102-1197-9201 RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD MULTIQUAL ASSAYED LOT 46030 CONTROLS TESTED ON A VITROS XT7600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE HIGHER THAN EXPECTED VITROS NA+ AND K+ RESULTS WAS USER ERROR, WHERE FIVE ATYPICAL CALIBRATIONS WERE GENERATED FROM VITROS CALIBRATOR LOT 0235 FLUIDS THAT WERE IMPROPERLY RECONSTITUTED. NO DETAILS WERE PROVIDED CONCERNING THE IMPROPER RECONSTITUTION. EXPECTED VITROS NA+ AND K+ RESULTS WERE OBTAINED AFTER CALIBRATING WITH AN ALTERNATE SET OF VITROS CALIBRATOR KIT LOT 0235 FLUIDS THAT WERE PROPERLY RECONSTITUTED. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC PERFORMANCE ISSUE WITH EITHER VITROS NA+ SLIDE LOT 4213-1185-0237 AND VITROS K+ SLIDE LOT 4102-1197-9201. NO DIAGNOSTIC WITHIN-RUN PRECISION TESTING WAS PERFORMED TO ASSESS THE PERFORMANCE OF THE VITROS XT7600 INTEGRATED SYSTEM, THEREFORE, AN INSTRUMENT RELATED PERFORMANCE ISSUE CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT.

    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+) SLIDE LOT 4213-1185-0237 AND VITROS POTASSIUM (K+) SLIDE LOT 4102-1197-9201 RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD MULTIQUAL ASSAYED LOT 46030 CONTROLS TESTED ON A VITROS XT7600 INTEGRATED SYSTEM. BIORAD LEVEL 1 NA+ RESULTS OF 193.5, 192.8, 191.1, 195.3 AND 194.9 MMOL/L VS. THE EXPECTED RESULT OF 114.99 MMOL/L BIORAD LEVEL 1 K+ RESULTS OF 4.48, 4.49, 4.48, 4.54 AND 4.55 MMOL/L VS. THE EXPECTED RESULT OF 2.58 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 HIGHER-THAN-EXPECTED RESULTS WERE OBTAINED FROM A NON-PATIENT QUALITY CONTROL SAMPLE, HOWEVER, UNKNOWN SAMPLES THAT MAY HAVE BEEN PATIENT SAMPLES WERE PROCESSED IN THE TIMEFRAME OF THE EVENT. THERE WAS 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 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185092 VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 IN-VITRO DIAGNOSTICS JIX ORTHO-CLINICAL DIAGNOSTICS, INC. 0235 10758750009503

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown