BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS DGXN SLIDES

    MDR report key: 11871646 · Received May 24, 2021

    Report

    Report Number
    1319809-2021-00091
    Event Type
    Malfunction
    Date Received
    May 24, 2021
    Date of Event
    March 10, 2021
    Report Date
    May 24, 2021
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LFM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED LOWER THAN EXPECTED VITROS DGXN RESULTS OBTAINED FROM A CAP PROFICIENCY FLUID AND A VITROS TDM PERFORMANCE VERIFIER QUALITY CONTROL FLUID WHEN PROCESSED ON TWO DIFFERENT LOTS OF VITROS DGXN MICROSLIDES USING A VITROS 5600 INTEGRATED SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE WAS NOT DETERMINED. HOWEVER, ONGOING TRACKING AND TRENDING OF COMPLAINT DATA HAS IDENTIFIED AN INCREASE IN CUSTOMER COMPLAINTS FOR DGXN FOR IMPRECISION, QCL, QCH AND ACCURACY HIGH/LOW. ORTHO HAS OPENED A QUALITY RECORD TO FURTHER INVESTIGATE ((B)(4)). HISTORICAL QC ON BOTH DGXN SLIDE LOTS INDICATES WITHIN - LAB IMPRECISION. IN ADDITION, WITHIN-RUN PRECISION TESTING WAS PERFORMED ON THREE DIFFERENT DGXN SLIDE LOTS AND THE RESULTS WERE UNACCEPTABLE ON ALL THREE LOTS. THE CUSTOMER ALSO PROCESSED WITHIN-RUN PRECISION TESTING USING VITROS CRBM ASSAY AND THOSE PRECISION RESULTS WERE ACCEPTABLE. THE ACCEPTABLE CRBM PRECISION RESULTS INDICATE THAT THE VITROS 5600 ANALYZER WAS PERFORMING AS EXPECTED. IT COULD NOT BE CONCLUDED WHETHER THE ISSUE IS DUE TO THE DGXN SLIDES OR AN ISSUE WITH THE VITROS ANALYZER THAT ONLY IMPACTS DGXN. AN INSTRUMENT ISSUE COULD NOT BE CONFIRMED OR RULED OUT AS A CONTRIBUTOR TO THE EVENT. THE CUSTOMER CLEANED THE MICROSLIDE INCUBATOR AND EVAPORATION CAPS. FOLLOWING THE INCUBATOR CLEANING, THE CUSTOMER PROCESSED AN 18 REPLICATE WITHIN A RUN PRECISION TEST WITH ALTERNATE DGXN SLIDE LOT 1923-0260-8026 AND OBTAINED ACCEPTABLE RESULTS. THE CUSTOMER HAD DEPLETED THE INVENTORY OF THE PREVIOUS 2 DGXN LOTS SO IT COULD NOT BE CONFIRMED IF THE ISSUE WAS RELATED TO THE DGXN MICROSLIDE LOTS OR THE VITROS ANALYZER. THE LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM A CAP PROFICIENCY FLUID AND A VITROS PV CONTROL FLUID. ORTHO WAS NOT MADE AWARE OF ANY ERRONEOUS PATIENTS RESULTS OBTAINED OR REPORTED FROM THE LABORATORY. HOWEVER, THE INVESTIGATION CANNOT DEFINITIVELY CONCLUDE THAT PATIENT RESULTS WERE NOT AND WOULD NOT BE AFFECTED IF THE ISSUE WERE TO RECUR. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED LOWER THAN EXPECTED VITROS DIGOXIN (DGXN) RESULTS OBTAINED FROM A COLLEGE OF AMERICAN PATHOLOGIST (CAP) PROFICIENCY FLUID AND A VITROS TDM PERFORMANCE VERIFIER QUALITY CONTROL FLUID WHEN PROCESSED ON TWO DIFFERENT LOTS OF VITROS DGXN MICROSLIDES USING A VITROS 5600 INTEGRATED SYSTEM. DGXN SLIDE LOT 1922-0259-6001: CAP PROFICIENCY CHM-02 = 1.3 VERSUS EXPECTED 2.05 NG/ML. DGXN SLIDE LOT 1922-0259-6552: TDM PV3 = 1.65 VERSUS EXPECTED 2.61 NG/ML. THE LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM A CAP PROFICIENCY FLUID AND A VITROS PV CONTROL FLUID. ORTHO WAS NOT MADE AWARE OF ANY ERRONEOUS PATIENTS RESULTS OBTAINED OR REPORTED FROM THE LABORATORY. HOWEVER, THE INVESTIGATION CANNOT DEFINITIVELY CONCLUDE THAT PATIENT RESULTS WERE NOT AND WOULD NOT BE AFFECTED IF THE ISSUE WERE TO RECUR. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO MDR¿S 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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766384 VITROS CHEMISTRY PRODUCTS DGXN SLIDES IN-VITRO DIAGNOSTICS LFM ORTHO-CLINICAL DIAGNOSTICS 1922-0259-6001

    Patients

    Seq Age Sex Outcome Treatment
    1