BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS CREA SLIDES

    MDR report key: 14829227 · Received June 27, 2022

    Report

    Report Number
    1319809-2022-00032
    Event Type
    Malfunction
    Date Received
    June 27, 2022
    Date of Event
    May 30, 2022
    Report Date
    June 27, 2022
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JFY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS DETERMINED THAT A NON-REPRODUCIBLE, LOWER THAN EXPECTED CREATININE (CREA) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS CREA SLIDES LOT 1531-3512-0423 ON A VITROS 5600 INTEGRATED SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE OF THE LOWER THAN EXPECTED VITROS CREA PATIENT SAMPLE RESULT COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR OF THE EVENT. 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. ADDITIONALLY, PRE-ANALYTICAL SAMPLE MIX-UP CANNOT BE COMPLETELY RULED OUT DUE TO THE CHANGING HEMOLYSIS INDEX OF THE SAMPLE AND THE DIFFERENCE IN SAMPLE VISCOSITY BETWEEN RUNS, ALTHOUGH THIS COULD NOT BE CONFIRMED. BASED ON ACCEPTABLE HISTORICAL QUALITY CONTROL (QC) RESULTS, A VITROS CREA REAGENT LOT 1531-3512-0423 PERFORMANCE ISSUE OR AN ISSUE WITH THE VITROS 5600 INTEGRATED SYSTEM IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. 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 1531-3512-0423. EMAIL ADDRESS FOR CONTACT OFFICE IS (B)(6).

    Description of Event or Problem · 0

    THE INVESTIGATION HAS DETERMINED THAT A NON-REPRODUCIBLE, LOWER THAN EXPECTED CREATININE (CREA) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS CREA SLIDES LOT 1531-3512-0423 ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT 1 SAMPLE RESULT OF 1.1 MG/DL VS. THE EXPECTED RESULT OF 4.7 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER THAN EXPECTED VITROS CREA RESULT WAS REPORTED FROM THE LABORATORY. A PHYSICIAN QUESTIONED THE RESULT AND CORRECTED REPORTS WERE LATER ISSUED. NO TREATMENT WAS INITIATED, ALTERED OR STOPPED BASED ON THE LOWER THAN EXPECTED RESULT AND THERE HAVE BEEN NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750306 VITROS CHEMISTRY PRODUCTS CREA SLIDES IN-VITRO DIAGNOSTICS JFY ORTHO-CLINICAL DIAGNOSTICS 1531-3512-0423

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown