BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS DGXN SLIDES

    MDR report key: 12514286 · Received September 22, 2021

    Report

    Report Number
    1319809-2021-00140
    Event Type
    Malfunction
    Date Received
    September 22, 2021
    Date of Event
    May 30, 2021
    Report Date
    September 22, 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 · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM A VITROS TDM PV FLUID USING VITROS DIGOXIN (DGXN) SLIDE LOT 1922-0259-6552 TESTED ON A VITROS 5600 SYSTEM. THE INVESTIGATION COULD NOT DETERMINE THE ASSIGNABLE CAUSE. HISTORICAL QUALITY CONTROL RESULTS OBTAINED FROM VITROS DGXN SLIDE LOT 1922-0259-6552 DETERMINED WITHIN-LAB IMPRECISION WAS OBTAINED FROM BOTH VITROS TDM PV LEVELS, INDICATING THE VITROS DGXN SLIDES WERE NOT PERFORMING AS INTENDED ON THE VITROS 5600 SYSTEM. IT IS NOTED THAT AN ACCEPTABLE VITROS DGXN RESULT WAS OBTAINED FROM TDM PV (B)(4) THE DAY AFTER THE EVENT USING AN ALTERNATE SLIDE CARTRIDGE OF VITROS DGXN SLIDE LOT 1922-0259-6552, INDICATING THE SLIDE CARTRIDGE IN USE ON THE DATE OF THE EVENT CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT, CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUES WITH VITROS DGXN SLIDE LOT 1922-0259-6552. VITROS DGXN WITHIN-RUN PRECISION TESTS THAT WERE USED TO ASSESS THE PERFORMANCE OF THE VITROS 5600 SYSTEM WERE ACCEPTABLE FOUR MONTHS AFTER THE EVENTS OCCURRED, INDICATING THE VITROS 5600 SYSTEM IS CURRENTLY PERFORMING AS INTENDED. HOWEVER, SINCE NO DIAGNOSTIC PRECISION TESTING WAS PERFORMED AT THE TIME OF THE EVENTS, A TRANSIENT INSTRUMENT PERFORMANCE ISSUE CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. IMPROPER PRE-ANALYTICAL SAMPLE HANDLING COULD HAVE POTENTIALLY CONTRIBUTED TO THE EVENT, HOWEVER, SINCE THE EVENT OCCURRED FOUR MONTHS AGO THIS COULD NOT BE CONFIRMED EMAIL ADDRESS FOR CONTACT OFFICE ABOVE IS (B)(4).

    Description of Event or Problem · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM A VITROS TDM PV FLUID USING VITROS DIGOXIN (DGXN) SLIDE LOT 1922-0259-6552 TESTED ON A VITROS 5600 SYSTEM. VITROS TDM III W7852 VITROS DGXN RESULTS OF 1.70 AND 1.85 NG/ML VS. THE EXPECTED RESULT OF 2.54 NG/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 VITROS DGXN RESULTS OBTAINED FROM VITROS TDM PV W7852 WERE FROM A NON-PATIENT SAMPLE, HOWEVER, THE INVESTIGATION COULD NOT RULE OUT THAT PATIENT SAMPLES WERE NOT, OR COULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO REPORTED ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO 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
    1411991 VITROS CHEMISTRY PRODUCTS DGXN SLIDES IN-VITRO DIAGNOSTICS LFM ORTHO-CLINICAL DIAGNOSTICS 1922-0259-6552

    Patients

    Seq Age Sex Outcome Treatment
    1