BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 18856679 · Received March 7, 2024

    Report

    Report Number
    1319681-2024-00019
    Event Type
    Malfunction
    Date Received
    March 7, 2024
    Date of Event
    February 8, 2024
    Report Date
    March 5, 2024
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    UDI-DI
    10758750002740
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VALPROIC ACID (VALP) RESULTS WERE OBTAINED FROM NON-VITROS BIORAD QUALITY CONTROL FLUIDS PROCESSED USING VITROS CHEMISTRY PRODUCTS VALP REAGENT LOT 2511-32-1564 ON A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT IS AN INSTRUMENT RELATED ISSUE. FOLLOWING SERVICE ACTIONS ON THE VITROS 5600 SYSTEM PERFORMED BY AN ORTHO FIELD ENGINEER WHICH INCLUDED DEFROSTING THE REAGENT COOLER AND UNCLOGGING A DRAIN LINE, HIGHER THAN EXPECTED VITROS VALP RESULTS WERE OBTAINED FROM THE BIORAD QUALITY CONTROL FLUIDS. THE VITROS VALP INSTRUCTIONS FOR USE STATES THAT THE VITROS VALP ASSAY MAY NEED TO BE CALIBRATED: -IF QUALITY CONTROL RESULTS ARE CONSISTENTLY OUTSIDE ACCEPTABLE RANGE. -AFTER CERTAIN SERVICE PROCEDURES HAVE BEEN PERFORMED. FOLLOWING A RECALIBRATION EVENT, QUALITY CONTROL RESULTS FOR VITROS VALP RETURNED TO EXPECTATIONS.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VALPROIC ACID (VALP) RESULTS WERE OBTAINED FROM NON-VITROS BIORAD QUALITY CONTROL FLUIDS PROCESSED USING VITROS CHEMISTRY PRODUCTS VALP REAGENT LOT 2511-32-1564 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LOT 85340 LEVEL 1 RESULTS OF 53.3, 66.18, 64.0, 55.78 AND 60.1 UG/ML VS AN EXPECTED RESULT OF 38.19 UG/ML BIORAD LOT 85340 LEVEL 2 RESULTS OF 113.1, 128.2, 117.9, 116.1 AND 113.1 UG/ML VS AN EXPECTED RESULT OF 81.34 UG/ML BIORAD LOT 85340 LEVEL 3 RESULTS OF >150.0, >150.0, >150.0 AND >150.0 UG/ML VS AN EXPECTED RESULT OF 112.51 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 HIGHER THAN EXPECTED RESULTS WERE FROM QUALITY CONTROL FLUIDS AND WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER CONFIRMED THAT PATIENT SAMPLES WERE NOT PROCESSED DURING THE TIMEFRAME OF THE EVENT. THERE WERE NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4) .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2170390 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS, INC. 10758750002740

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown