BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 7611819 · Received June 18, 2018

    Report

    Report Number
    1319681-2018-00055
    Event Type
    Malfunction
    Date Received
    June 18, 2018
    Date of Event
    March 15, 2018
    Report Date
    June 18, 2018
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS CRBM RESULTS WERE OBTAINED DURING AN INTERNAL SPECIMEN MATRIX STUDY. THE TESTING WAS PERFORMED USING THREE DIFFERENT LOTS OF VITROS CRBM ON A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE WAS DETERMINED TO BE CONSISTENT WITH AN INSTRUMENT ISSUE. DURING THE TIME INTERVAL THAT THE LOW CRBM RESULTS WERE OBTAINED, THE VITROS INSTRUMENT WAS INTERMITTENTLY POSTING IMMUNORATE WASH CONDITION CODES WHICH INDICATE THE SLIDE WAS NOT WASHED CORRECTLY. THE OPERATOR PERFORMED MAINTENANCE ON THE IMMUNO RATE SUBSYSTEM WHICH INCLUDED REPLACING THE TIP AND FORCING AIR THROUGH THE TUBING. THE MAINTENANCE ACTIONS RESOLVED THE IMMUNO RATE WASH CODES AND THE CRBM RESULTS OBTAINED POST MAINTENANCE WERE CONSISTENT WITH THE EXPECTED CRBM RESULTS.

    Description of Event or Problem · 1

    AN ORTHO INTERNAL EMPLOYEE OBTAINED LOWER THAN EXPECTED VITROS CRBM RESULTS ON THREE SAMPLES FROM THE SAME WHOLE BLOOD POOL WHEN THE SAMPLES WERE PROCESSED USING THREE (3) SEPARATE LOTS OF VITROS CHEMISTRY PRODUCTS CRBM SLIDES ON A VITROS 5600 INTEGRATED SYSTEM. SAMPLE S-38 = 5.3 UG/ML VERSUS EXPECTED 13.6 UG/ML; SAMPLE NH-40 = 8.3, 9.2 UG/ML VERSUS EXPECTED 15.9 UG/ML; SAMPLE S-29 = 7.1 UG/ML VERSUS EXPECTED 10.2 UG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. NO RESULTS WERE REPORTED TO A PHYSICIAN AS THE TESTING WAS INTERNAL TO ORTHO, HOWEVER; THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS COULD NOT BE AFFECTED OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED IN A HEALTH CARE SETTING. THERE WAS NO REPORTED ALLEGATION OF PATIENT HARM. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454251 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1