BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 8428076 · Received March 18, 2019

    Report

    Report Number
    1319681-2019-00021
    Event Type
    Malfunction
    Date Received
    March 18, 2019
    Date of Event
    February 20, 2019
    Report Date
    March 18, 2019
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A LOWER THAN EXPECTED VITROS DIGOXIN (DGXN) RESULT WAS ATTAINED FROM A CALIBRATOR FLUID, RUN AS AN UNKNOWN FLUID DURING TROUBLESHOOTING, USING VITROS CHEMISTRY PRODUCTS DGXN SLIDES IN COMBINATION WITH A VITROS 5600 INTEGRATED SYSTEM. THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY ASSIGNABLE CAUSE OF THE EVENT WAS AN INSTRUMENT RELATED ISSUE ASSOCIATED WITH THE IMMUNO RATE (IR) WASH MODULE. THE CUSTOMER INDICATED THAT THEY HAD EXPERIENCED CONDITION CODES INTERMITTENTLY WHILE TRYING TO CALIBRATE ON (B)(6) 2019. BASED ON THESE CONDITION CODES, A FIELD ENGINEER VISITED THE SITE AND PERFORMED SERVICE ACTIONS WHICH INCLUDED REPLACING THE IR WASH CAM AND THE IR PUMP TUBING AS WELL AS COMPLETING ALL REQUIRED ADJUSTMENTS. CALIBRATION AND QUALITY CONTROL RESPONSES WERE WITHIN EXPECTATIONS POST-SERVICE INDICATING THAT THE VITROS 5600 INTEGRATED SYSTEM WAS RETURNED TO OPTIMAL PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED A LOWER THAN EXPECTED VITROS DIGOXIN (DGXN) RESULT FROM A CALIBRATOR FLUID WHICH WAS TESTED AS AN UNKNOWN FLUID PROCESSED USING VITROS CHEMISTRY PRODUCTS DGXN SLIDES IN COMBINATION WITH A VITROS 5600 INTEGRATED SYSTEM. VITROS DGXN RESULT OF 1.47 NG/ML VERSUS AN EXPECTED RESULT OF 2.02 NG/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 DGXN RESULT WAS OBTAINED WHEN PROCESSING A CALIBRATOR FLUID AND RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. HOWEVER, IT CANNOT BE CONCLUDED THAT PATIENT SAMPLE RESULTS WERE NOT AFFECTED OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. 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
    224145 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1