BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 8642058 · Received May 24, 2019

    Report

    Report Number
    1319681-2019-00046
    Event Type
    Malfunction
    Date Received
    May 24, 2019
    Date of Event
    March 19, 2019
    Report Date
    May 24, 2019
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONCLUDED THAT A LOWER THAN EXPECTED VITROS CHEMISTRY PRODUCTS PHENYTOIN (PHYT) RESULT WAS ATTAINED FROM A (B)(4) PROFICIENCY SAMPLE USING VITROS PHYT SLIDES IN COMBINATION WITH A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THIS EVENT IS USER ERROR DUE TO AN INAPPROPRIATE INTERPRETATION OF AN ANALYZER CONDITION CODE. THE VITROS 5600 INTEGRATED SYSTEM DID NOT GENERATE A VITROS PHYT RESULT OF < 3.0 UG/ML FOR THE SAMPLE, WHICH WAS THE VALUE REPORTED BY THE CUSTOMER. AN ANALYZER CONDITION CODE OCCURRED WHEN THE SAMPLE WAS INITIALLY RUN, AND NO PHYT RESULT WAS GENERATED AT THAT TIME. THE INVESTIGATION FOUND NO EVIDENCE TO SUGGEST A MALFUNCTION OF THE VITROS 5600 INTEGRATED SYSTEM. QUALITY CONTROL RESULTS FOR VITROS PHYT LOT 2618-0169-6213 INDICATED TO BE ACCEPTABLE DURING THE TIMEFRAME THAT THE PROFICIENCY SAMPLES WERE TESTED. A PERFORMANCE ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. NO VITROS PHYT PATIENT RESULTS WERE QUESTIONED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLES WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A LOWER THAN EXPECTED VITROS PHENYTOIN (PHYT) RESULT FROM A (B)(4) PROFICIENCY SAMPLE USING VITROS CHEMISTRY PRODUCTS PHENYTOIN SLIDES ON A VITROS 5600 INTEGRATED SYSTEM. (B)(4) PROFICIENCY SAMPLE CHM-04: VITROS PHYT RESULT OF <3.0 UG/ML VERSUS THE EXPECTED RESULT OF 5.84 UG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER THAN EXPECTED VITROS PHYT RESULT WAS OBTAINED WHEN PROCESSING CAP FLUIDS WITH NO PATIENT RESULTS BEING REPORTED OUTSIDE OF THE LABORATORY. THERE WERE NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436191 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1