BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VANC REAGENT

    MDR report key: 21559267 · Received March 10, 2025

    Report

    Report Number
    1319808-2025-00010
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    February 12, 2025
    Report Date
    March 10, 2025
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    LEH
    UDI-DI
    10758750006731
    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 HAS DETERMINED THAT LOWER THAN EXPECTED VANCOMYCIN (VANC) RESULTS WERE OBTAINED FROM A NON-VITROS BIORAD QUALITY CONTROL FLUID AND A HIGHER THAN EXPECTED RESULT WAS OBTAINED FROM A VITROS THERAPEUTIC DRUG MONITORING PERFORMANCE VERIFIER PROCESSED USING VITROS CHEMISTRY PRODUCTS VANC REAGENT LOT 2514-56-2737 ON A VITROS 5600 INTEGRATED SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE OF THE EVENT COULD NOT BE DETERMINED. A POSSIBLE CAUSE OF THE EVENT IS A VITROS VANC LOT 2514-56-2737 PACK CONDITION RELATED ISSUE. THE REAGENT PACKS FOR AN ALTERNATE LOT OF VITROS VANC WERE FOUND TO HAVE ARRIVED FROZEN AT THE CUSTOMER SITE LIKELY DUE TO THE EXTREMELY COLD TEMPERATURES BEING EXPERIENCED OUTSIDE THE CUSTOMER SITE. IT IS POSSIBLE THE PACKS FOR LOT 2514-56-2737 WERE EXPOSED TO SIMILAR CONDITIONS, HOWEVER, THIS WAS NOT ABLE TO BE CONFIRMED. AN INSTRUMENT RELATED ISSUE IS NOT A LIKELY CONTRIBUTOR OF THE EVENT AS ALTERNATE VITROS ASSAYS WERE NOT AFFECTED. ADDITIONALLY, THE QUALITY CONTROL RESULTS FOR THE CUSTOMER'S PREVIOUS LOT OF VITROS VANC REAGENT WERE WITHIN EXPECTATIONS AROUND THE TIMEFRAME OF THE EVENT. AN ISSUE RELATED TO THE QUALITY CONTROL FLUIDS IS NOT A LIKELY CONTRIBUTOR OF THE EVENT AS UNACCEPTABLE RESULTS WERE OBTAINED FROM BOTH A NON-VITROS BIORAD CONTROL FLUID AS WELL AS FROM A VITROS TDM PV FLUID. IN ADDITION, THE SAME CONTROL FLUIDS PRODUCED ACCEPTABLE RESULTS FOR THE VITROS VALP ASSAY USED AT THE CUSTOMER SITE. 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 2514-56-2737.

    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 BIORAD QUALITY CONTROL FLUID AND A HIGHER THAN EXPECTED RESULT WAS OBTAINED FROM A VITROS THERAPEUTIC DRUG MONITORING (TDM) PERFORMANCE VERIFIER (PV) PROCESSED USING VITROS CHEMISTRY PRODUCTS VANC REAGENT LOT 2514-56-2737 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LOT 85360 LEVEL 2 RESULTS OF 9.88, 9.89, 9.95 AND 9.89 UG/ML VS AN EXPECTED RESULT OF 16.35 UG/ML VITROS TDM PV I LOT C2150 RESULT OF 16.07 UG/ML VS AN EXPECTED RESULT OF 7.5 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 AND HIGHER THAN EXPECTED VITROS VANC RESULTS WERE OBTAINED FROM QUALITY CONTROL FLUIDS AND NO RESULTS WERE REPORTED FROM THE LABORATORY. THE CUSTOMER CONFIRMED THAT NO PATIENT SAMPLES WERE PROCESSED USING THE AFFECTED VITROS VANC REAGENT LOT. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE HAVE BEEN NO REPORTED ALLEGATIONS 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 609127.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1822017 VITROS CHEMISTRY PRODUCTS VANC REAGENT IN-VITRO DIAGNOSTICS LEH ORTHO-CLINICAL DIAGNOSTICS, INC. 2514-56-2737 10758750006731

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown