BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS CREA SLIDES

    MDR report key: 19780543 · Received July 19, 2024

    Report

    Report Number
    1319809-2024-00055
    Event Type
    Malfunction
    Date Received
    July 19, 2024
    Date of Event
    June 20, 2024
    Report Date
    July 17, 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 1513-3549-1074 ON A VITROS 5600 INTEGRATED SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE OF THE EVENT COULD NOT BE DETERMINED. A POSSIBLE CAUSE OF THE EVENT IS A SAMPLE RELATED ISSUE. THE HEMOLYSIS VALUE OF THE INITIAL RUN FOR VITROS CREA WAS SIGNIFICANTLY HIGHER THAN FOR THE REPEAT RESULTS. ADDITIONALLY, THE INITIAL RESULT OF AN ALTERNATE VITROS ASSAY FOR THE SAMPLE WAS SIGNIFICANTLY LOWER THAN THE REPEAT RESULTS AND WAS NOT REPRODUCIBLE. 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. IN ADDITION, AS NO INFORMATION REGARDING WHETHER THE PATIENT, WHO WAS A KIDNEY TRANSPLANT RECIPIENT, HAD BEEN TAKING ANY MEDICATIONS OR SUPPLEMENTS AROUND THE TIME OF THE EVENT WAS PROVIDED, A SAMPLE INTERFERENT CANNOT BE RULED OUT AS A POSSIBLE CONTRIBUTOR OF THE EVENT. AS A BARCODE WAS USED TO PROCESS THE SAMPLE ON THE INITIAL RUN AS WELL AS ONE OF THE REPEAT RUNS, A SAMPLE MIX-UP IS NOT A LIKELY CONTRIBUTOR OF THE EVENT. BASED ON HISTORICAL QUALITY CONTROL RESULTS A VITROS CREA LOT 1513-3549-1074 RELATED ISSUE IS NOT A LIKELY CONTRIBUTING FACTOR OF THE EVENT. FURTHERMORE, 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 1513-3549-1074. HOWEVER, AN INDIVIDUAL SLIDE RELATED ISSUE COULD NOT BE RULED OUT. AS NO DIAGNOSTIC PRECISION TESTING WAS PERFORMED ON THE VITROS 5600 INTEGRATED SYSTEM AN INSTRUMENT RELATED ISSUE COULD NOT BE COMPLETELY RULED OUT AS A CONTRIBUTOR OF THE EVENT. HOWEVER, THERE WAS NO INDICATION THAT THE VITROS 5600 SYSTEM MALFUNCTIONED.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT 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 1513-3549-1074 ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT SAMPLE VITROS CREA RESULT OF 0.66 MG/DL VERSUS AN EXPECTED RESULT OF 6.87 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 OUTSIDE OF THE LABORATORY. HOWEVER, A PHYSICIAN QUESTIONED THE RESULT AND NO TREATMENT WAS INITIATED, ALTERED OR STOPPED BASED ON THE RESULT. A CORRECTED REPORT WAS LATER ISSUED FOR THE PATIENT. THERE WAS NO REPORTED ALLEGATION OF PATIENT HARM AS A RESULT OF THIS 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
    1551940 VITROS CHEMISTRY PRODUCTS CREA SLIDES IN-VITRO DIAGNOSTICS JFY ORTHO-CLINICAL DIAGNOSTICS, INC. 1513-3549-1074 10758750002849

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown