BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS CREA SLIDES

    MDR report key: 7143616 · Received December 22, 2017

    Report

    Report Number
    1319809-2017-00196
    Event Type
    Malfunction
    Date Received
    December 22, 2017
    Date of Event
    December 9, 2017
    Report Date
    December 22, 2017
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JFY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONCLUDES THAT A LOWER THAN EXPECTED VITROS CREA RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE TESTED ON A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THIS EVENT IS UNKNOWN. THERE IS NO INDICATION OF A SYSTEMIC REAGENT ISSUE. THE ISSUE IS ISOLATED TO A SINGLE SLIDE. AN INSTRUMENT RELATED ISSUE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR. SERVICE ACTIONS WERE COMPLETED TO REPLACE THE DISPENSE BLADE, ALTHOUGH, IT COULD NOT BE CONFIRMED IF THE SERVICE ACTIONS WERE RELATED TO THE LOWER THAN EXPECTED RESULT. IN ADDITION, PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR, AS THE CUSTOMER IS NOT ADHERING TO THE SAMPLE COLLECTION DEVICE MANUFACTURER¿S RECOMMENDATIONS FOR SAMPLE CENTRIFUGATION. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLES, ALTHOUGH THIS COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A NON-REPRODUCIBLE, LOWER THAN EXPECTED VITROS CREA RESULT FROM A SINGLE PATIENT SAMPLE TESTED ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT RESULT OF <0.25 MG/DL VERSUS THE EXPECTED RESULT OF 1.84 MG/DL. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE LOWER THAN EXPECTED RESULT WAS REPORTED OUTSIDE THE LABORATORY, HOWEVER, THE RESULT WAS QUESTIONED BY THE PHYSICIAN. A CORRECTED REPORT WAS SENT TO THE PHYSICIAN AND THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924132 VITROS CHEMISTRY PRODUCTS CREA SLIDES IN-VITRO DIAGNOSTIC JFY ORTHO-CLINICAL DIAGNOSTICS 1512-3465-9829

    Patients

    Seq Age Sex Outcome Treatment
    1