BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VANC REAGENT

    MDR report key: 9810608 · Received March 10, 2020

    Report

    Report Number
    1319808-2020-00015
    Event Type
    Malfunction
    Date Received
    March 10, 2020
    Date of Event
    February 13, 2020
    Report Date
    March 10, 2020
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS VANC QUALITY CONTROL RESULTS WERE OBTAINED FROM VITROS THERAPEUTIC DRUG MONITORING PERFORMANCE VERIFIERS USING VITROS CHEMISTRY PRODUCTS VANC REAGENT ON A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT WAS NOT ABLE TO BE DETERMINED. THE MOST LIKELY CAUSE OF THE EVENT IS A SUBOPTIMAL CALIBRATION. AFTER A CALIBRATION, QC RESULTS WERE HIGHER THAN EXPECTED. THE CALIBRATION PARAMETERS FROM THIS CALIBRATION EVENT WERE NOT TYPICAL. HOWEVER, BECAUSE THE CUSTOMER DID NOT RUN THE TDM CONTROLS FOLLOWING THE RECALIBRATION EVENT, A SUBOPTIMAL CALIBRATION COULD NOT BE ENTIRELY CONFIRMED AS THE CAUSE OF THE EVENT. THE CAUSE OF THE SUBOPTIMAL CALIBRATION IS UNKNOWN. AN INSTRUMENT RELATED ISSUE WITH THE VITROS 5600 INTEGRATED SYSTEM COULD NOT BE ENTIRELY RULED OUT AS A CONTRIBUTING FACTOR OF THE SUBOPTIMAL CALIBRATION AS THE INSTRUMENT WAS EXPERIENCING MECHANICAL ISSUES AROUND THE TIME OF THE EVENT. HOWEVER, COMPLETED SERVICE ACTIONS WERE NOT INDICATIVE OF AN ISSUE THAT WOULD LIKELY HAVE CONTRIBUTED TO THE EVENT. AFTER SERVICE ACTIONS WERE COMPLETED, A WITHIN RUN VITROS VANC PRECISION TEST YIELDED RESULTS THAT WERE ACCEPTABLE. HOWEVER, BECAUSE PRE-SERVICE PRECISION WAS NOT COMPLETED AND A MARKER PRECISION TEST WAS NOT COMPLETED, AN ISSUE WITH THE VITROS 5600 INTEGRATED SYSTEM COULD NOT BE ENTIRELY RULED OUT AS A CONTRIBUTOR OF THE EVENT. BASED ON HISTORICAL QUALITY CONTROL RESULTS AN ISSUE WITH VITROS VANC REAGENT LOT 2514-40-7718 COULD NOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT. HOWEVER, FOLLOWING A RECALIBRATION EVENT PRECISION TESTING RESULTS WERE ACCEPTABLE USING VITROS VANC LOT 2514-40-7718. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS VANC LOT 2514-40-7718. BECAUSE THE CUSTOMER DID NOT RUN THE TDM PV¿S FOLLOWING THE RECALIBRATION EVENT, AN ISSUE RELATED TO THE TDM PV FLUIDS COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR OF THE EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS TECHNICAL SERVICE CENTER (TSC) TO REPORT HIGHER THAN EXPECTED QUALITY CONTROL (QC) RESULTS OBTAINED FROM VITROS THERAPEUTIC DRUG MONITORING PERFORMANCE VERIFIERS (TDM PV) PROCESSED USING VITROS CHEMISTRY PRODUCTS VANC (VANCOMYCIN) REAGENT ON A VITROS 5600 INTEGRATED SYSTEM. VITROS TDM PVI LOT M7416 RESULT OF 20.64 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 HIGHER THAN EXPECTED RESULT WAS FROM A QC FLUID AND WAS NOT REPORTED OUTSIDE OF THE LABORATORY. HOWEVER, THE INVESTIGATION WAS UNABLE TO CONFIRM THAT PATIENT SAMPLES WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. 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. COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278472 VITROS CHEMISTRY PRODUCTS VANC REAGENT IN VITRO DIAGNOSTICS LEH ORTHO-CLINICAL DIAGNOSTICS 2514-40-7718

    Patients

    Seq Age Sex Outcome Treatment
    1