BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS LI SLIDES

    MDR report key: 22741933 · Received August 7, 2025

    Report

    Report Number
    1319809-2025-00069
    Event Type
    Malfunction
    Date Received
    August 7, 2025
    Date of Event
    June 20, 2025
    Report Date
    August 7, 2025
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JIH
    UDI-DI
    10758750009466
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED LITHIUM (LI) RESULTS AND HIGHER THAN EXPECTED AMMONIA (AMON) RESULTS WERE OBTAINED FROM COLLEGE OF AMERICAN PATHOLOGISTS (CAP) PROFICIENCY SAMPLE FLUIDS USING VITROS CHEMISTRY PRODUCTS LI REAGENT LOTS 3129-0124-0247 AND 3130-0125-4996 AND VITROS CHEMISTRY PRODUCTS AMON REAGENT LOTS 1020-0267-1157 AND 1020- 0267-3613 ON TWO VITROS XT 7600 INTEGRATED SYSTEMS. AN ASSIGNABLE CAUSE OF THE EVENT COULD NOT BE DETERMINED. HISTORICAL QC RESULTS LEADING UP TO THE EVENT DEMONSTRATED SLIGHT INACCURACY AND IMPRECISION FOR BOTH VITROS ANALYTES. HOWEVER, THE INACCURACY AND IMPRECISION WAS SLIGHT WHEN COMPARED TO THE MAGNITUDE OF BIAS ASSOCIATED WITH THE HIGHER THAN (VITROS AMON) AND LOWER THAN (VITROS LI) EXPECTED RESULTS (CAP MEAN VALUE). THEREFORE, A VITROS LI OR VITROS AMON REAGENT ISSUE IS AN UNLIKELY CONTRIBUTOR TO THIS EVENT BUT CANNOT BE COMPLETELY RULED OUT AS A CONTRIBUTING FACTOR. ADDITIONALLY, CONTINUAL TRACKING AND TRENDING DOES NOT INDICATE A QUALITY PERFORMANCE ISSUE WITH VITROS LI (REAGENT LOTS 3129-0124-0247 AND 3130-0125-4996) OR VITROS AMON (REAGENT LOTS 1020- 0267-1157 AND 1020-0267-3613). A VITROS ALKP DIAGNOSTIC PRECISION TEST INDICATED THAT J2 WAS PERFORMING AS EXPECTED BUT J1 WAS NOT AT THE TIME OF TESTING. AN ORTHO FE ARRIVED ONSITE TO ADDRESS THE FAILED PRECISION TEST ON J1 AND PERFORMED THE FOLLOWING OPTIMIZATIONS: CLEANING THE MICROSLIDE SUBSYSTEM, REPLACING WEAR PADS, DISPENSE BLADE ASSEMBLY AND DISPENSE BLADE, AND PERFORMING SUBSEQUENT ADJUSTMENTS. A POSTSERVICE ALKP DIAGNOSTIC PRECISION STUDY WAS WITHIN ACCEPTABLE GUIDELINES, CONFIRMING THAT THE VITROS XT 7600 INTEGRATED SYSTEM WAS OPERATING AS INTENDED AFTER SERVICE INTERVENTIONS. HOWEVER, IT SHOULD BE NOTED THAT THE LOWER THAN EXPECTED (VITROS LI) RESULTS WERE ALSO OBSERVED ON J2, WHICH PASSED THE VITROS ALKP DIAGNOSTIC PRECISION STUDY. THIS WOULD SUGGEST THAT THE UNEXPECTED VITROS PROFICIENCY SURVEY SAMPLE RESULTS WERE NOT DUE TO AN INSTRUMENT-RELATED ISSUE. IN ADDITION, SINCE NO DIAGNOSTIC WITHIN-RUN PRECISION TESTING WAS PERFORMED TO VERIFY INSTRUMENT PERFORMANCE, AN INSTRUMENT PERFORMANCE ISSUE CANNOT BE COMPLETELY RULED OUT AS CONTRIBUTING TO THE EVENT(S). AS NO INFORMATION ABOUT THE PREPARATION, HANDLING AND STORAGE PROTOCOL FOR THE CAP FLUIDS WAS PROVIDED, AN ISSUE RELATED TO THE CAP FLUID SAMPLE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR OF THE EVENT. THE RESULT FOR THE AFFECTED SAMPLE WAS REPRODUCIBLE.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED LITHIUM (LI) RESULTS AND HIGHER THAN EXPECTED AMMONIA (AMON) RESULTS WERE OBTAINED FROM COLLEGE OF AMERICAN PATHOLOGISTS (CAP) PROFICIENCY SAMPLE FLUIDS USING VITROS CHEMISTRY PRODUCTS LI REAGENT LOTS 3129-0124-0247 AND 3130-0125-4996 AND VITROS CHEMISTRY PRODUCTS AMON REAGENT LOTS 1020-0267-1157 AND 1020- 0267-3613 ON TWO VITROS XT 7600 INTEGRATED SYSTEMS. RESULTS FROM VITROS XT7600 SYSTEM, S/N (B)(6) (J1) VITROS LI SLIDE LOT 3129-0124-0247 CAP SAMPLE CHM-10 VITROS LI RESULT OF 0.9 MMOL/L VS AN EXPECTED RESULT OF 1.7 MMOL/L RESULTS FROM VITROS XT7600 SYSTEM, S/N (B)(6) (J2) VITROS LI SLIDE LOT 3129-0124-0247 CAP SAMPLE CHM-10 VITROS LI RESULT OF 1.0 MMOL/L VS AN EXPECTED RESULT OF 1.7 MMOL/L VITROS LI SLIDE LOT 3130-0125-4996 CAP SAMPLE CHM-10 VITROS LI RESULT OF 0.9 MMOL/L VS AN EXPECTED RESULT OF 1.7 MMOL/L RESULTS FROM VITROS XT7600 INTEGRATED SYSTEM, S/N (B)(6) (J2) VITROS AMON SLIDE LOT 1020-0267-1157 CAP SAMPLE CHM-10 VITROS AMON RESULT OF 459.0 UMOL/L VS AN EXPECTED RESULT OF 366.2 UMOL/L VITROS AMON SLIDE LOT 1020-0267-3613 CAP SAMPLE CHM-10 VITROS AMON RESULT OF > 500 UMOL/L VS AN EXPECTED RESULT OF 366.2 UMOL/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 VITROS AMON RESULTS AND THE LOWER THAN VITROS LI RESULTS WERE FROM A NONPATIENT PROFICIENCY FLUID. THE CUSTOMER STATED THAT PATIENT SAMPLE RESULTS HAD NOT BEEN AFFECTED, HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO REPORTED ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER FOUR OF FIVE 3500A FORMS BEING SUBMITTED FOR THIS EVENT AS FIVE DEVICES WERE INVOLVED. 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
    411164 VITROS CHEMISTRY PRODUCTS LI SLIDES IN-VITRO DIAGNOSTICS JIH ORTHO-CLINICAL DIAGNOSTICS, INC. 3129-0124-0247 10758750009466

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown