BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS CREA SLIDES

    MDR report key: 20088066 · Received August 28, 2024

    Report

    Report Number
    1319809-2024-00063
    Event Type
    Malfunction
    Date Received
    August 28, 2024
    Date of Event
    August 1, 2024
    Report Date
    August 28, 2024
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JFY
    UDI-DI
    10758750002849
    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 A NON-REPRODUCIBLE, LOWER THAN EXPECTED VITROS CREATININE (CREA) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS CREA SLIDES LOT 1514-3550-1920 ON A VITROS 5600 INTEGRATED SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE OF THE EVENT COULD NOT BE DETERMINED. BASED ON ACCEPTABLE HISTORICAL QUALITY CONTROL RESULTS, A VITROS CREA LOT 1514-3550-1920 RELATED ISSUE IS NOT A LIKELY CONTRIBUTING FACTOR OF THE EVENT. ADDITIONALLY, CONTINUAL TRACKING AND TRENDING OF COMPLAINT DATA HAS NOT IDENTIFIED ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH VITROS CREA REAGENT LOT 1514-3550-1920. ACCEPTABLE RESULTS FROM WITHIN-RUN PRECISION TESTING INDICATE THAT AN ISSUE WITH THE VITROS 5600 INTEGRATED SYSTEM WAS NOT A LIKELY 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 MANUFACTURER'S RECOMMENDED CENTRIFUGATION PROTOCOL. IMPROPER PRE-ANALYTICAL SAMPLE HANDLING COULD HAVE CONTRIBUTED TO THE EVENT. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTIONS CENTER (TSC) TO REPORT A NON-REPRODUCIBLE, LOWER THAN EXPECTED VITROS CREATININE (CREA) RESULT OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS CREA SLIDES ON A VITROS 5600 INTEGRATED SYSTEM. VITROS CREA PATIENT RESULT OF 0.54 MG/DL VERSUS THE EXPECTED RESULT OF 2.68 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THE RESULTS WERE TO RECUR UNDETECTED. THE LOWER THAN EXPECTED VITROS CREA RESULT WAS NOT REPORTED FROM THE LABORATORY. THERE WERE NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THE EVENT. 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
    1548773 VITROS CHEMISTRY PRODUCTS CREA SLIDES IN-VITRO DIAGNOSTICS JFY ORTHO-CLINICAL DIAGNOSTICS, INC. 1514-3550-1920 10758750002849

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown