BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 20268061 · Received September 20, 2024

    Report

    Report Number
    1319681-2024-00051
    Event Type
    Malfunction
    Date Received
    September 20, 2024
    Date of Event
    August 26, 2024
    Report Date
    September 19, 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 CONCLUDED THAT LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF VITROS LIQUID PERFORMANCE VERIFIER II, LOT E1517, USING VITROS AMON SLIDE LOT 1020-0265-0698 ON A VITROS 5600 INTEGRATED SYSTEM. THE INVESTIGATION CONCLUDED THE MOST LIKELY ASSIGNABLE CAUSE IS INSTRUMENT RELATED ASSOCIATED WITH MICROSLIDE INCUBATOR CONTAMINATION. AFTER AN ORTHO FIELD ENGINEER CLEANED THE MICROSLIDE INCUBATOR AND REPLACED THE MICROSLIDE EVAPORATION CAPS AND BEARING PADS, IMPROVED VITROS AMON PRECISION WAS OBTAINED.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF VITROS LIQUID PERFORMANCE VERIFIER II, LOT E1517, USING VITROS AMON SLIDE LOT 1020-0265-0698 ON A VITROS 5600 INTEGRATED SYSTEM. VITROS LIQUID PERFORMANCE VERIFIER II LOT E1517 RESULTS OF 153.0 AND 148.7 UMOL/L VS. THE EXPECTED RESULT OF 191.9 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. 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
    1668174 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS, INC. 10758750002740

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown