BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 16472162 · Received March 2, 2023

    Report

    Report Number
    0001319681-2023-00014
    Event Type
    Malfunction
    Date Received
    March 2, 2023
    Date of Event
    February 3, 2023
    Report Date
    March 2, 2023
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    UDI-DI
    10758750002740
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS CONCLUDED THAT HIGHER AND LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM THREE DIFFERENT LEVELS OF NON-VITROS BIORAD CONTROLS USING TWO DIFFERENT VITROS VALPROIC ACID (VALP) REAGENT LOTS ON A VITROS 5600 INTEGRATED SYSTEM. THE MOST LIKELY ASSIGNABLE CAUSE OF THE EVENT WAS AN INSTRUMENT RELATED ISSUE. THE VITROS 5600 INTEGRATED SYSTEM WAS GENERATING TM5-42B (SECONDARY UIA METERING ASPIRATE BUBBLES) CONDITION CODES DURING THE TIMEFRAME OF THE EVENT. ACCEPTABLE VITROS VALP PERFORMANCE WAS OBTAINED AFTER REPLACING THE PROBOSCIS/PISTON ASSEMBLY. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS VALP REAGENT LOT 2511-31-9784 OR REAGENT LOT 2511-31-9557.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER AND LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM THREE DIFFERENT LEVELS OF NON-VITROS BIORAD CONTROLS USING TWO DIFFERENT VITROS VALPROIC ACID (VALP) REAGENT LOTS ON A VITROS 5600 INTEGRATED SYSTEM. VITROS VALP LOT 2511-31-9784 BIORAD LEVEL 1 LOT 85300 VITROS VALP RESULTS OF 45.9, 45.9 AND 51.2 UG/ML VS. THE EXPECTED RESULT OF 35.0 UG/ML BIORAD LEVEL 2 LOT 85300 VITROS VALP RESULTS OF 85.4, 84.8, 96.5, 86.0 AND 86.9 UG/ML VS. THE EXPECTED RESULT OF 65.5 UG/ML BIORAD LEVEL 3 LOT 85300 VITROS VALP RESULTS OF 40.9, 133.8, 128.1 AND 128.6 UG/ML VS. THE EXPECTED RESULT OF 100.0 UG/ML VITROS VALP LOT 2511-31-9557 BIORAD LEVEL 1 LOT 85300 VITROS VALP RESULTS OF 46.4 AND 17.1 UG/ML VS. THE EXPECTED RESULT OF 35.0 UG/ML BIORAD LEVEL 2 LOT 85300 VITROS VALP RESULTS OF 88.3, 85.0, 84.2 AND 41.7 UG/ML VS. THE EXPECTED RESULT OF 65.5 UG/ML BIORAD LEVEL 3 LOT 85300 VITROS VALP RESULT OF 68.3 UG/ML VS. THE EXPECTED RESULT OF 100.0 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 CUSTOMER MADE NO ALLEGATIONS THAT PATIENT SAMPLES WERE AFFECTED AND THERE WERE NO REPORTED ALLEGATIONS OF HARM AS A RESULT OF THIS EVENT. THERE WAS NO ALLEGATION 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
    1826726 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS, INC. 6802413 10758750002740

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown