BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 10312988 · Received July 23, 2020

    Report

    Report Number
    1319681-2020-00050
    Event Type
    Malfunction
    Date Received
    July 23, 2020
    Date of Event
    July 3, 2020
    Report Date
    July 23, 2020
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS DETERMINED THAT HIGHER THAN EXPECTED VITROS CK-MB QUALITY CONTROL FLUID RESULTS WERE OBTAINED FROM A VITROS CLINIQA LIQUID CARDIAC MARKER (LCM) QC FLUID USING VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT LOT 2740 ON A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT IS AN INSTRUMENT RELATED ISSUE. WITHIN LABORATORY IMPRECISION WAS OBSERVED WITH THE HISTORICAL QUALITY CONTROL RESULTS INDICATING AN ISSUE WITH THE VITROS 5600 INTEGRATED SYSTEM. IN ADDITION, MULTIPLE ANALYZER CONDITION CODES WERE POSTED ON THE INSTRUMENT AROUND THE TIME OF THE EVENT. AN ORTHO FIELD ENGINEER (FE) COMPLETED SERVICE ACTIONS ON THE VITROS 5600 SYSTEM THAT INCLUDED CLEANING THE WASH HEADS, CHECKING THE ASPIRATE TIPS, REPLACING BOTH ASPIRATE FILTERS, REPLACING THE SIGNAL REAGENT (SR) TIPS AND THE STRAWS IN THE SR REAGENT PACK. THE ORTHO FE THEN INSPECTED THE SR PUMPS FOR LEAKS, REPLACED THE SR PACK, REPLACED THE REAGENT METERING PROBOSCIS, AND VERIFIED ALL THE MICROWELL INCUBATOR ADJUSTMENTS. QC FLUID RESULTS OBTAINED AFTER COMPLETED SERVICE ACTIONS INDICATE THAT THE PERFORMANCE OF THE VITROS 5600 INTEGRATED SYSTEM HAS BEEN RETURNED TO EXPECTATIONS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTIONS CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS CK-MB QUALITY CONTROL (QC) RESULTS OBTAINED FROM VITROS CLINIQA LIQUID CARDIAC MARKERS (LCM) USING VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT ON A VITROS 5600 INTEGRATED SYSTEM. CLINIQA LCM LOT 19070011 RESULTS OF 4.911, 4.756, 4.913, 5.005, 4.973 AND 5.009 NG/ML VS AN EXPECTED RESULT OF 3.010 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 HIGHER THAN EXPECTED VITROS CK-MB QC RESULTS WERE NOT REPORTED FROM THE LABORATORY. NO PATIENT SAMPLE RESULTS WERE QUESTIONED. HOWEVER, THE INVESTIGATION CANNOT CONFIRM THAT PATIENT SAMPLE RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBERS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782157 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1