BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS GLU SLIDES

    MDR report key: 17784387 · Received September 20, 2023

    Report

    Report Number
    0001319809-2023-00121
    Event Type
    Malfunction
    Date Received
    September 20, 2023
    Date of Event
    August 23, 2023
    Report Date
    September 18, 2023
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    CGA
    UDI-DI
    10758750009572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS GLU RESULTS WERE OBTAINED FROM TWO DIFFERENT PATIENT SAMPLES TESTED ON A VITROS XT7600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE FOR THIS EVENT COULD NOT BE DETERMINED. THE HIGHER THAN EXPECTED VITROS GLU RESULTS FOR BOTH PATIENT SAMPLES AND THE EXPECTED GLU RESULTS WERE OBTAINED FROM THE SAME VITROS GLU SLIDE CARTRIDGE. IT IS POSSIBLE THAT THERE IS A POTENTIAL PERFORMANCE ISSUE WITH SOME, BUT NOT ALL, VITROS GLU SLIDES FROM THE AFFECTED SLIDE CARTRIDGE. BASED ON A REVIEW OF HISTORICAL QUALITY CONTROL RESULTS, THERE WAS NO INDICATION OF A PERFORMANCE ISSUE AT THE CUSTOMER SITE WITH VITROS GLU SLIDE LOT 0023-3233-9086. HOWEVER, CONTINUAL TRACK AND TRENDING OF COMPLAINTS IDENTIFIED A SLIGHT INCREASE IN COMPLAINTS FOR HIGHER THAN EXPECTED AND NON-REPRODUCIBLE RESULTS USING VITROS GLU SLIDE LOT 0023-3233-9086, AND WITH VITROS GLU SLIDES FROM COATING 3233. THEREFORE, A VITROS GLU SLIDE LOT ISSUE COULD NOT BE ENTIRELY RULED OUT AS A CONTRIBUTOR TO THE EVENT. NO DIAGNOSTIC WITHIN RUN PRECISION TESTING WAS PERFORMED TO ASSESS THE PERFORMANCE OF THE VITROS XT7600 INTEGRATED SYSTEM. THEREFORE, IT IS UNKNOWN IF THE VITROS XT7600 INTEGRATED SYSTEM WAS PERFORMING AS INTENDED AND AN INSTRUMENT ISSUE CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT. PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR, AS IT IS UNKNOWN IF THE CUSTOMER WAS FOLLOWING THE SAMPLE COLLECTION DEVICE MANUFACTURE¿S RECOMMENDATION FOR SAMPLE CENTRIFUGATION AND CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, COULD HAVE BEEN PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS GLU RESULTS WERE OBTAINED FROM TWO DIFFERENT PATIENT SAMPLES TESTED ON A VITROS XT7600 INTEGRATED SYSTEM. PATIENT 1: VITROS GLU RESULTS OF >625, >1250, 402 MG/DL VS. THE EXPECTED RESULT OF 178.0 MG/DL. PATIENT 2: VITROS GLU RESULT OF >625, >1250 MG/DL VS. THE EXPECTED RESULT OF 68.0 MG/DL. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER THAN EXPECTED VITROS GLU PATIENT RESULTS WERE NOT REPORTED FROM THE LABORATORY. THERE WERE NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER FIVE OF FIVE MDR¿S FOR THIS EVENT. FIVE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FIVE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77421 VITROS CHEMISTRY PRODUCTS GLU SLIDES IN VITRO DIAGNOSTICS CGA ORTHO-CLINICAL DIAGNOSTICS, INC. 1707801 0023-3233-9086 10758750009572

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown