BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VANC REAGENT

    MDR report key: 9588884 · Received January 14, 2020

    Report

    Report Number
    1319808-2020-00002
    Event Type
    Malfunction
    Date Received
    January 14, 2020
    Date of Event
    December 13, 2019
    Report Date
    January 14, 2020
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED A LOWER THAN EXPECTED VITROS VANC RESULT WAS OBTAINED FROM ONE PATIENT CORRELATION SAMPLE USING VANC REAGENT LOT 2514-40-7718 ON TWO VITROS 5,1FS CHEMISTRY SYSTEMS WHEN COMPARED TO RESULTS OBTAINED FROM A NON-VITROS METHOD. THE DEFINITIVE ASSIGNABLE CAUSE OF THIS EVENT IS UNKNOWN. THE VITROS VANC RESULTS WHEN PROCESSING VITROS TDM PERFORMANCE VERIFIERS AS WELL AS BIORAD QUALITY CONTROL FLUIDS WERE WITHIN RANGE INDICATING ACCEPTABLE ACCURACY AFTER THE INITIAL CALIBRATION ON 13 DECEMBER 2019. IN ADDITION, CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS VANC REAGENT LOT 2514-40-7718. DIAGNOSTIC WITHIN RUN PRECISION TESTS PRODUCED RESULTS WITHIN ORTHO GUIDELINES INDICATING BOTH VITROS 5,1FS CHEMISTRY SYSTEMS ARE PERFORMING AS EXPECTED. THE SAMPLES USED FOR THE CORRELATION WERE INITIALLY TESTED ON 13 DECEMBER 2019 AND FROZEN PRIOR TO TRANSPORTING TO THE ALTERNATE FACILITY WHERE THEY WERE PROCESSED ON 17 DECEMBER 2019. THE VITROS VANC INSTRUCTIONS FOR USE STATES THAT SAMPLES MAY BE STORED AT 2 ¿ 8 DEGREES C, OR FROZEN AT </ = 20 C FOR UP TO 14 DAYS. HOWEVER, SAMPLE HANDLING INFORMATION FROM THE ALTERNATE FACILITY WAS NOT OBTAINED. A PRE-ANALYTICAL SAMPLE HANDLING ISSUE COULD NOT BE RULED OUT OR CONFIRMED AS A CAUSE OF THE LOWER THAN EXPECTED VITROS VANC RESULT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SUPPORT CENTER (TSC) AFTER OBSERVING LOWER THAN EXPECTED VITROS VANC RESULTS OBTAINED WHEN USING A NEW LOT OF VITROS VANC REAGENT ON TWO DIFFERENT VITROS 5,1FS CHEMISTRY SYSTEMS. (B)(4), VITROS VANC RESULT 9.3 UG/ML VERSUS NON-VITROS SIEMENS VANC RESULT 15.9 UG/ML. (B)(4), VITROS VANC RESULT 9.4 UG/ML VERSUS NON-VITROS SIEMENS VANC RESULT 15.9 UG/ML . BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER THAN EXPECTED VITROS VANC RESULTS WERE OBTAINED DURING A PATIENT SAMPLE CORRELATION. THE PATIENT RESULTS OBTAINED DURING THE CORRELATION WERE NOT REPORTED OUTSIDE OF THE LABORATORY AND THERE WAS NO REPORTED 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
    52712 VITROS CHEMISTRY PRODUCTS VANC REAGENT IN VITRO DIAGNOSTICS LEH ORTHO-CLINICAL DIAGNOSTICS 2514-40-7118

    Patients

    Seq Age Sex Outcome Treatment
    1