BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VANC REAGENT

    MDR report key: 13738258 · Received March 11, 2022

    Report

    Report Number
    1319808-2022-00003
    Event Type
    Malfunction
    Date Received
    March 11, 2022
    Date of Event
    February 12, 2022
    Report Date
    March 11, 2022
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT HIGHER AND LOWER THAN EXPECTED VITROS VANCOMYCIN (VANC) QUALITY CONTROL RESULTS WERE OBTAINED FROM NON-VITROS THERMOFISHER MAS QUALITY CONTROL FLUIDS USING VITROS CHEMISTRY PRODUCTS VANC REAGENT LOT 2514-46-9257 ON A VITROS XT7600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT IS RELATED TO AN ISSUE WITH VITROS VANC LOT 2514-46-9257 PACK SEQUENCE # (B)(4). THE ISSUE WITH THE PACK COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. ALTHOUGH THIS VANC LOT WAS ONLY IN USE FOR A SHORT TIME PRIOR TO THE UNEXPECTED RESULTS, THE QUALITY CONTROL RESULTS WERE WITHIN EXPECTATION PRIOR TO LOADING PACK SEQUENCE # (B)(4). ADDITIONALLY, RESULTS WERE ACCEPTABLE WHEN A NEW PACK FROM THE SAME LOT WAS LOADED AND RUN USING THE SAME CALIBRATION PARAMETERS. THEREFORE, AN OVERALL ISSUE WITH VITROS VANC REAGENT LOT 2514-46-9257 IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. ALTHOUGH A DIAGNOSTIC PRECISION TEST WAS NOT RUN, AN INSTRUMENT RELATED ISSUE WITH THE VITROS XT7600 INTEGRATED SYSTEM IS NOT A LIKELY CONTRIBUTOR TO THE EVENT AS VITROS VANC LOT 2514-46-9257 WAS PRODUCING ACCEPTABLE RESULTS BEFORE THE AFFECTED PACK WAS PUT INTO USE, AND WHEN A NEW PACK (SEQUENCE # (B)(4)) WAS PUT INTO USE, WITH NO ACTIONS PERFORMED ON THE ANALYZER. (B)(4).

    Description of Event or Problem · 0

    THE INVESTIGATION DETERMINED THAT HIGHER AND LOWER THAN EXPECTED VITROS VANCOMYCIN (VANC) QUALITY CONTROL RESULTS WERE OBTAINED FROM NON-VITROS THERMOFISHER MAS QUALITY CONTROL FLUIDS USING VITROS CHEMISTRY PRODUCTS VANC REAGENT LOT 2514-46-9257 ON A VITROS XT7600 INTEGRATED SYSTEM. MAS QC LEVEL 1 RESULTS OF 16.03 AND 16.21 UG/ML VERSUS THE EXPECTED RESULT OF 6.34 UG/ML. MAS QC LEVEL 2 RESULTS OF <5.0 AND <5.0 UG/ML VERSUS THE EXPECTED RESULT OF 18.6 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 AND LOWER THAN EXPECTED RESULTS WERE FROM A QC FLUID AND WAS NOT REPORTED OUTSIDE OF THE LABORATORY. 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 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1220930 VITROS CHEMISTRY PRODUCTS VANC REAGENT IN-VITRO DIAGNOSTICS LEH ORTHO-CLINICAL DIAGNOSTICS 2514-46-9257

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown