BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS DGXN SLIDES

    MDR report key: 11851407 · Received May 19, 2021

    Report

    Report Number
    1319809-2021-00088
    Event Type
    Malfunction
    Date Received
    May 19, 2021
    Date of Event
    April 22, 2021
    Report Date
    May 19, 2021
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LFM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS DGXN RESULTS WERE OBTAINED FROM A SINGLE VITROS PV II LOT T7911 QUALITY CONTROL FLUID USING VITROS DGXN SLIDE LOT 1922-0259-6173, TESTED ON A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT IS UNKNOWN. AN INSTRUMENT PERFORMANCE ISSUE CANNOT BE RULED OUT OR CONFIRMED AS A CONTRIBUTOR TO THE EVENT SINCE DIAGNOSTIC WITHIN-RUN PRECISION TESTING WAS WITHIN ACCEPTABLE GUIDELINES; HOWEVER, A WITHIN-RUN PRECISION TEST PROCESSED SPECIFICALLY USING VITROS DGXN WAS OUTSIDE OF ACCEPTABLE GUIDELINES. A PERFORMANCE ISSUE WITH VITROS DGXN SLIDE LOT 1922-0259-6173 CANNOT BE RULED OUT OR CONFIRMED. A VITROS DGXN WITHIN-RUN PRECISION TEST WAS OUTSIDE OF ACCEPTABLE GUIDELINES ON THE EFFECTED VITROS 5600 SYSTEM BUT WAS WITHIN ACCEPTABLE GUIDELINES ON AN ALTERNATE VITROS 5600 SYSTEM ON SITE. IN ADDITION, ORTHO CURRENTLY HAS AN OPEN INVESTIGATION FOR THE VITROS DGXN ASSAY FOR AN INCREASE IN CUSTOMER COMPLAINTS FOR DGXN FOR IMPRECISION, QCL, QCH AND ACCURACY HIGH/LOW. AN ISSUE WITH VITROS IWF LOT U8611 CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT, AS THE ISSUE APPEARED WHEN THIS IWF LOT WAS PUT INTO USE. HOWEVER, OTHER VITROS IMMUNO-RATE MICROSLIDE ASSAYS USING THE SAME IWF LOT WERE PERFORMING AS INTENDED. EMAIL ADDRESS FOR CONTACT OFFICE IS (B)(6).

    Description of Event or Problem · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS DIGOXIN (DGXN) RESULTS WERE OBTAINED FROM A SINGLE VITROS PERFORMANCE VERIFIER (PV) II LOT T7911 QUALITY CONTROL FLUID USING VITROS DGXN SLIDE LOT 1922-0259-6173, TESTED ON A VITROS 5600 INTEGRATED SYSTEM. VITROS PV II T7911 RESULT OF 2.57, 1.82, 2.50, 2.33, 2.49, 2.55, 2.27 AND 2.45 NMOL/L VS. EXPECTED RESULT OF 3.64 NMOL/L. THE AFFECTED QUALITY CONTROL WAS A NON-PATIENT SAMPLE, AND THE CUSTOMER MADE NO INDICATION THAT PATIENT SAMPLES WERE AFFECTED. HOWEVER, THE INVESTIGATION COULD NOT RULE OUT THAT PATIENT SAMPLE RESULTS WERE NOT OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO REPORTED ALLEGATION OF PATIENT HARM. THIS REPORT IS NUMBER SIX OF EIGHT MDR¿S FOR THIS EVENT. EIGHT 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS EIGHT 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
    744405 VITROS IMMUNODIAGNOSTIC PRODUCTS DGXN SLIDES IN-VITRO DIAGNOSTICS LFM ORTHO-CLINICAL DIAGNOSTICS 1922-0259-6173

    Patients

    Seq Age Sex Outcome Treatment
    1