BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 24820679 · Received April 8, 2026

    Report

    Report Number
    1319681-2026-00024
    Event Type
    Malfunction
    Date Received
    April 8, 2026
    Date of Event
    March 12, 2026
    Report Date
    April 8, 2026
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    UDI-DI
    10758750002740
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED HSTNI RESULTS WERE OBTAINED WHEN THE CUSTOMER WAS PROCESSING VITROS HSTNI LOW CONTROLS (LOT 0350) USING VITROS IMMUNODIAGNOSTICS PRODUCTS HS TROPONIN I (HSTNI) REAGENT PACK LOT 1510 ON A VITROS 5600 INTEGRATED SYSTEM. THE MOST LIKELY CAUSE OF THE EVENT IS AN INSTRUMENT RELATED ISSUE, SPECIFICALLY THE CUSTOMER USING A CHLORINE-BASED BLEACH SOLUTION TO CLEAN THE LABORATORY WHERE THE VITROS 5600 INTEGRATED SYSTEM IS LOCATED. QC RESULTS LEADING UP TO THE EVENT WERE UNACCEPTABLE AND PRE-SERVICE WITHIN-RUN DIAGNOSTIC PRECISION TESTING FAILED, SUGGESTING AN INSTRUMENT ISSUE. FOLLOWING DECONTAMINATION OF THE LABORATORY AND INSTRUMENT, WITHIN-RUN DIAGNOSTIC PRECISION TESTING WAS ACCEPTABLE AND VITROS RESULTS FROM QC TESTING WERE DEEMED ACCEPTABLE.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED HSTNI RESULTS OBTAINED WHEN THE CUSTOMER WAS PROCESSING VITROS HSTNI LOW CONTROLS (LOT 0350) USING VITROS IMMUNODIAGNOSTICS PRODUCTS HS TROPONIN I (HSTNI) REAGENT PACK LOT 1510 ON A VITROS 5600 INTEGRATED SYSTEM. RESULTS OF 29.34, 28.44 AND 29.09 NG/L VERSUS THE PACKAGE INSERT MEAN VALUE OF 9.39 NG/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 HSTNI RESULTS WERE OBTAINED WHEN THE CUSTOMER WAS PROCESSING A NON-PATIENT FLUID. HOWEVER, THE INVESTIGATION CANNOT RULE OUT THAT PATIENT SAMPLE RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED THERE HAS BEEN NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER 1(B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239065 VITROS 5600 INTEGRATED SYSTEM CLINICAL CHEMISTRY JJE ORTHO-CLINICAL DIAGNOSTICS, INC. 10758750002740

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown