BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VANC REAGENT

    MDR report key: 24100945 · Received January 16, 2026

    Report

    Report Number
    1319808-2026-00002
    Event Type
    Malfunction
    Date Received
    January 16, 2026
    Date of Event
    December 19, 2025
    Report Date
    January 16, 2026
    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 RESULTS WERE OBTAINED FROM TWO DIFFERENT PATIENT SAMPLES AND A SINGLE LEVEL OF NON-VITROS BIORAD LIQUICHEK IMMUNOASSAY PLUS LOT 1003930 CONTROL USING VITROS VANCOMYCIN (VANC) REAGENT LOT 2514-57-3336 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE LOWER THAN EXPECTED RESULTS WAS A REAGENT PACK RELATED ISSUE. THE AFFECTED RESULTS WERE ISOLATED TO TWO DIFFERENT REAGENT PACKS. THE ISSUE WITH THE AFFECTED REAGENT PACKS IS UNKNOWN. THE INVENTORY OF VITROS VANC REAGENT LOT 2514-57-3336 WAS DEPLETED AT THE SITE AND ACCEPTABLE PERFORMANCE WAS OBTAINED USING AN ALTERNATE REAGENT LOT. EXCEPT FOR THE AFFECTED REAGENT PACKS, THERE WAS NO INDICATION THAT VITROS VANC REAGENT LOT 2514-57-3336 WAS NOT PERFORMING AS INTENDED, BASED ON HISTORICAL QUALITY CONTROL RESULTS. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC PERFORMANCE ISSUE WITH VITROS VANC REAGENT LOT 2514-57-3336. ALTHOUGH NO DIAGNOSTIC WITHIN-RUN PRECISION TESTING WAS PERFORMED TO ASSESS THE PERFORMANCE OF THE VITROS XT 7600 SYSTEM, ACCEPTABLE RESULTS WERE OBTAINED FROM AN ALTERNATE VITROS VANC REAGENT LOT WITHOUT PERFORMING ANY ACTIONS TO OPTIMIZE THE INSTRUMENT.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM TWO DIFFERENT PATIENT SAMPLES AND A SINGLE LEVEL OF NON-VITROS BIORAD LIQUICHEK IMMUNOASSAY PLUS LOT 1003930 CONTROL USING VITROS VANCOMYCIN (VANC) REAGENT LOT 2514-57-3336 ON A VITROS XT 7600 INTEGRATED SYSTEM. PATIENT SAMPLE 1 RESULTS OF 9.23 UG/ML VS. THE EXPECTED RESULT OF 16.35 UG/ML PATIENT SAMPLE 2 RESULT OF 8.76 UG/ML VS. THE EXPECTED RESULT OF 15.07 UG/ML BIORAD LEVEL 2 CONTROL RESULTS OF 8.70 AND 7.37 UG/ML VS. THE BASELINE MEAN RESULT OF 16.47 UG/ML. THE LOWER THAN EXPECTED VITROS VANC PATIENT SAMPLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY, HOWEVER, THE RESULTS WERE QUESTIONED BY THE HOSPITAL PHARMACY. CORRECTED REPORTS WERE ISSUED AND THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO MDRS FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 613113.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161552 VITROS CHEMISTRY PRODUCTS VANC REAGENT IN-VITRO DIAGNOSTICS LEH ORTHO-CLINICAL DIAGNOSTICS, INC. 2514-57-3336 10758750006731

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown