BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VANC REAGENT

    MDR report key: 19722300 · Received July 11, 2024

    Report

    Report Number
    1319808-2024-00019
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Date of Event
    June 13, 2024
    Report Date
    July 9, 2024
    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 VITROS VANCOMYCIN (VANC) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF VITROS THERAPEUTIC DRUG MONITORING PERFORMANCE VERIFIER (TDM PV) III, LOT B1736 AND A SINGLE LEVEL OF NON-VITROS BIORAD IMMUNOASSAY PLUS CONTROL, LOT 85360 TESTED ON A VITROS XT7600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT COULD NOT BE DETERMINED. BASED ON HISTORICAL QUALITY CONTROL RESULTS, A VITROS VANC REAGENT LOT 2514-54-1972 PERFORMANCE ISSUE CANNOT BE RULED OUT AS A CONTRIBUTOR OF THE EVENT. THE LOWER THAN EXPECTED RESULTS WERE ISOLATED TO TWO VITROS VANC LOT 2514-54-1972 REAGENT PACKS, THEREFORE, A PERFORMANCE ISSUE WITH THE REAGENT PACKS IN USE CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. HOWEVER, BOTH ACCEPTABLE AND UNACCEPTABLE RESULTS WERE OBTAINED FROM ONE OF THE TWO REAGENT PACKS, THEREFORE, IT CANNOT BE CONFIRMED THE AFFECTED REAGENT PACKS WERE THE ASSIGNABLE CAUSE OF THE EVENT. 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 2514-54-1972. VITROS VANC WITHIN-RUN PRECISION TESTING INDICATED VITROS VANC LOT 2514-54-1972 WAS PERFORMING AS INTENDED ON THE VITROS XT7600 INTEGRATED SYSTEM AND AN INSTRUMENT RELATED PERFORMANCE ISSUE DID NOT LIKELY CONTRIBUTE TO THE EVENT. HOWEVER, SINCE NO DIAGNOSTIC WITHIN-RUN PRECISION TESTING WAS PERFORMED TO VERIFY INSTRUMENT PERFORMANCE, AN INSTRUMENT-RELATED PERFORMANCE ISSUE CANNOT BE COMPLETELY RULED OUT AS CONTRIBUTING TO 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 VITROS VANCOMYCIN (VANC) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF VITROS THERAPEUTIC DRUG MONITORING PERFORMANCE VERIFIER (TDM PV) III, LOT B1736 AND A SINGLE LEVEL OF NON-VITROS BIORAD IMMUNOASSAY PLUS CONTROL, LOT 85360 TESTED ON A VITROS XT7600 INTEGRATED SYSTEM. VITROS TDM PV III LOT B1736 RESULTS OF <5.0 UG/ML (X3) VS. THE BASELINE MEAN OF 32.7 UG/ML BIORAD LOT 85360 LEVEL 3 RESULT OF <5.0 UG/ML VS. THE TARGET VALUE OF 27.03 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 RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. THE CUSTOMER MADE NO ALLEGATION THAT ERRONEOUS PATIENT RESULTS HAD BEEN REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM. THIS REPORT IS NUMBER TWO 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 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284050 VITROS CHEMISTRY PRODUCTS VANC REAGENT IN-VITRO DIAGNOSTICS LEH ORTHO-CLINICAL DIAGNOSTICS, INC. 2514-54-1972 10758750006731

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown