BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 20302268 · Received September 25, 2024

    Report

    Report Number
    1319681-2024-00053
    Event Type
    Malfunction
    Date Received
    September 25, 2024
    Date of Event
    July 9, 2024
    Report Date
    September 25, 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 LOWER THAN EXPECTED VITROS MYOGLOBIN (MYOG) LOT 2340 RESULTS WERE OBTAINED WHEN THE CUSTOMER WAS PROCESSING TWO LEVELS OF NON-VITROS ABORAD QUALITY CONTROL FLUID ON A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT IS AN INSTRUMENT RELATED ISSUE. LOWER THAN EXPECTED VITROS MYOG LOT 2340 RESULTS WERE OBTAINED FOR MULTIPLE LEVELS OF BIORAD QUALITY CONTROL FLUIDS STARTING ON (B)(6) 2024. IMPRECISION WAS ALSO OBSERVED ON MULTIPLE OTHER VITROS ASSAYS, ALTHOUGH NONE OF THE OTHER ASSAYS HAD RESULTS THAT BREACHED POTENTIAL HEALTH AND SAFETY CRITERIA. THE CUSTOMER REPLACED THE UIA METERING PROBOSCIS ON (B)(6) 2024, WHICH DID NOT RESOLVE THE ISSUE. ON (B)(6) 2024 AN ORTHO FIELD ENGINEER (FE) WENT TO THE CUSTOMER SITE AND PERFORMED SERVICE ACTIONS THAT INCLUDED CLEANING THE UIA METERING ASSEMBLY, REPLACING THE UIA METERING PUMP AND TRANSDUCER CABLES, AND REPLACING THE PINION ASSEMBLIES AS THEY WERE NOT ROTATING SMOOTHLY. THE ORTHO FE ALSO PERFORMED THE PINION PHASING AND UIA METERING ADJUSTMENTS AFTER REPLACEMENT. FOLLOWING THESE ACTIONS, VITROS MYOG LOT 2340 QUALITY CONTROL RESULTS HAVE BEEN WITHIN EXPECTATION SINCE (B)(6) 2024. ONGOING TRACKING AND TRENDING OF COMPLAINT DATA HAS NOT IDENTIFIED ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH VITROS MYOG LOT 2340.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS MYOGLOBIN (MYOG) LOT 2340 RESULTS WERE OBTAINED WHEN THE CUSTOMER WAS PROCESSING TWO LEVELS OF NON-VITROS BIORAD QUALITY CONTROL FLUID ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LEVEL 1C (LOW) LOT 67696 MYOG RESULTS OF 19.3, 105.7, 107.3, 99.6, 16.3, 108.1, 102.9, 110.8, 104.2, 104.5, 103.7, 109.1, 102.5, 104.7, 105.0, 90.5, AND 107.9 NG/ML VERSUS THE EXPECTED RESULT OF 122.0 NG/ML (CUSTOMERS BASELINE MEAN) BIORAD LEVEL 3 LOT 67693 MYOG RESULTS OF 33.8, 114.7, 26.9, AND 25.3 NG/ML VERSUS THE EXPECTED RESULT OF 550.8 NG/ML (BIORAD PEER MEAN) 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 MYOG RESULTS WERE OBTAINED WHEN THE CUSTOMER WAS PROCESSING A NON-PATIENT FLUID. 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
    2185854 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS, INC. 10758750002740

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown