BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VANC REAGENT

    MDR report key: 23457843 · Received November 3, 2025

    Report

    Report Number
    1319808-2025-00031
    Event Type
    Malfunction
    Date Received
    November 3, 2025
    Date of Event
    October 6, 2025
    Report Date
    November 3, 2025
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    LEH
    UDI-DI
    10758750006731
    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 HAS DETERMINED THAT LOWER THAN EXPECTED VANCOMYCIN (VANC) RESULTS WERE OBTAINED FROM A NON-VITROS MAS QUALITY CONTROL (QC) FLUID USING VITROS CHEMISTRY PRODUCTS VANC REAGENT LOT 2514-57-3198 ON A VITROS 5600 INTEGRATED SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. HOWEVER, THE MOST LIKELY CAUSE OF THE EVENT IS A PACK RELATED ISSUE. THE LOWER THAN EXPECTED MAS QC RESULTS WERE OBTAINED AFTER THE CUSTOMER HAD LOADED A FRESH PACK OF VITROS VANC REAGENT LOT 2514-57-3198 (PACK ID 2694) ONTO THE INSTRUMENT. AFTER LOADING A DIFFERENT FRESH PACK OF VITROS VANC REAGENT LOT 2514-57-3198 (PACK ID 2695) ONTO THE INSTRUMENT ACCEPTABLE MAS QC RESULTS WERE OBTAINED. THE CUSTOMER THEN RELOADED THE AFFECTED PACK ID 2694 ONTO THE INSTRUMENT AND FURTHER UNACCEPTABLE MAS QC RESULTS WERE OBTAINED USING THE PACK. THE ISSUE WITH PACK ID 2694 IS UNKNOWN. BASED ON HISTORICAL QUALITY CONTROL RESULTS, A VITROS VANC REAGENT LOT 2514-57-3198 PERFORMANCE ISSUE CANNOT BE ENTIRELY RULED OUT AS A CONTRIBUTOR OF THE EVENT. HOWEVER, CONTINUAL TRACKING AND TRENDING OF COMPLAINT DATA HAS NOT IDENTIFIED ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH VITROS VANC REAGENT LOT 2514-57-3198. BOTH VITROS VANC WITHIN RUN PRECISION TESTING (USING PACK ID 2695) AND VITROS GENT DIAGNOSTIC PRECISION TESTING PERFORMED BY THE CUSTOMER ON THE VITROS 5600 INTEGRATED SYSTEM WERE WITHIN ORTHO ACCEPTABLE GUIDELINES SUGGESTING AN INSTRUMENT ISSUE WAS NOT LIKELY A CONTRIBUTING FACTOR OF THE EVENT.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VANCOMYCIN (VANC) RESULTS WERE OBTAINED FROM A NON-VITROS MAS QUALITY CONTROL (QC) FLUID USING VITROS CHEMISTRY PRODUCTS VANC REAGENT LOT 2514-57-3198 ON A VITROS 5600 INTEGRATED SYSTEM. MAS LOT CHU2512 LEVEL 3 VITROS VANC RESULTS OF <5 AND <5 UG/ML VS AN EXPECTED RESULT OF 29.86 UG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER-THAN-EXPECTED VITROS VANC RESULTS WERE OBTAINED FROM A QUALITY CONTROL FLUID AND NO RESULTS WERE REPORTED FROM THE LABORATORY. THE CUSTOMER DID NOT INDICATE THAT ANY PATIENT SAMPLE RESULTS HAD BEEN AFFECTED. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION 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
    1066972 VITROS CHEMISTRY PRODUCTS VANC REAGENT IN-VITRO DIAGNOSTICS LEH ORTHO-CLINICAL DIAGNOSTICS, INC. 2514-57-3198 10758750006731

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown