BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 4600 CHEMISTRY SYSTEM

    MDR report key: 24778105 · Received April 3, 2026

    Report

    Report Number
    1319681-2026-00020
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    March 6, 2026
    Report Date
    April 2, 2026
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    UDI-DI
    10758750012343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED, NON-REPRODUCIBLE VITROS NA+ RESULTS WERE OBTAINED FROM A SINGLE NON-VITROS BIORAD MULTIQUAL UNASSAYED CONTROL, LOT: 56760 FLUID AND A SINGLE VITROS PERFORMANCE VERIFIER (PV) I, LOT: E2828 FLUID USING VITROS NA+ SLIDE LOT: 4206-1179- 8305 ON A VITROS 4600 CHEMISTRY SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT IS AN INSTRUMENT PERFORMANCE ISSUE. A DIAGNOSTIC VITROS NA+ WITHIN-RUN PRECISION TEST WAS OUTSIDE OF THE ACCEPTANCE CRITERIA INDICATING A PERFORMANCE ISSUE WITH THE POTENTIOMETRIC SUBSYSTEM OF THE VITROS 4600 CHEMISTRY SYSTEM. THE CUSTOMER REPLACED THE EVAPORATION CAPS OF THE MICROSLIDE PM INCUBATOR, HOWEVER, DID NOT REPEAT A DIAGNOSTIC VITROS NA+ WITHIN-RUN PRECISION TEST TO ASSESS THE PERFORMANCE OF THE PM SUBSYSTEM AFTER REPLACING THE PM EVAPORATION CAPS. HISTORICAL QUALITY CONTROL RESULTS INDICATED THERE IS SLIGHT IMPRECISION OBSERVED USING THE BIORAD L1 CONTROL SINCE THE PM EVAPORATION CAPS WERE REPLACED. AN ORTHO FIELD ENGINEER WILL BE SENT ON SITE TO INVESTIGATE THE PERFORMANCE OF THE POTENTIOMETRIC SUBSYSTEM OF THE VITROS 4600 CHEMISTRY SYSTEM.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED, NON-REPRODUCIBLE VITROS NA+ RESULTS OBTAINED FROM A SINGLE NON-VITROS BIORAD MULTIQUAL UNASSAYED CONTROL, LOT 56760 FLUID AND A SINGLE VITROS PERFORMANCE VERIFIER (PV) I, LOT: E2828 FLUID USING VITROS CHEMISTRY PRODUCTS SODIUM (NA+) SLIDE LOT: 4206-1179- 8305 ON A VITROS 4600 CHEMISTRY SYSTEM. BIORAD L1 VITROS NA+ RESULT OF >250 MMOL/L VS. THE EXPECTED BASELINE MEAN RESULT OF 109.8 MMOL/L VITROS PV I LOT: E2828 VITROS NA+ RESULT OF >250 MMOL/L VS. THE EXPECTED RANGE OF MEANS MIDPOINT VALUE OF 125.8 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 VITROS NA+ RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUID, HOWEVER, PATIENT SAMPLE RESULTS WERE ALSO AFFECTED BUT THE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261562 VITROS 4600 CHEMISTRY SYSTEM CLINICAL CHEMISTRY JJE ORTHO-CLINICAL DIAGNOSTICS, INC. 10758750012343

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown