BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECI IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 8515948 · Received April 15, 2019

    Report

    Report Number
    1319681-2019-00030
    Event Type
    Malfunction
    Date Received
    April 15, 2019
    Date of Event
    March 26, 2019
    Report Date
    April 15, 2019
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KHO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED, VITROS TROPI ES RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. THE MOST LIKELY ASSIGNABLE CAUSE FOR THE HIGHER THAN EXPECTED RESULT IS INSTRUMENT RELATED. A BOWL OF BLEACH WAS FOUND UNDER AN AIR CONDITIONING UNIT ADJACENT TO THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM. SODIUM HYPOCHLORITE VAPOR IS KNOWN TO INTERFERE WITH VITROS ASSAYS THAT INCLUDE VITROS TROPI ES. POST CLEANING AND DECONTAMINATION ACTIONS PERFORMED BY AN ORTHO FIELD ENGINEER, VITROS TROPI ES QC FLUIDS TESTED WERE WITHIN EXPECTED LIMITS. IN ADDITION, PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR, AS IT WAS NOT POSSIBLE ESTABLISHED IF THE CUSTOMER WAS FOLLOWING THE SAMPLE COLLECTION DEVICE MANUFACTURE¿S RECOMMENDATION FOR SAMPLE CENTRIFUGATION. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED A NON-REPRODUCIBLE, HIGHER THAN EXPECTED, VITROS TROPI ES RESULT FROM A SINGLE PATIENT SAMPLE PROCESSED ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. PATIENT SAMPLE RESULT OF 0.170 NG/ML VERSUS THE EXPECTED RESULT OF <0.012 NG/ML. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF UNDETECTED. THE NON-REPRODUCIBLE, HIGHER THAN EXPECTED, VITROS TROPI ES RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND ANTI-ISCHEMIC TREATMENT WAS INITIATED ON THE PATIENT. PER MEDICAL CONSULT FROM AN ORTHO MEDICAL SAFETY OFFICER, LONG TERM SERIOUS HEALTH IMPACT DUE TO THIS SHORT-TERM EXPOSURE IS NOT ANTICIPATED. A CORRECTED REPORT WAS LATER ISSUED FOR THE SAMPLE. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF ACTUAL PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO).COMPLAINT NUMBERS: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308591 VITROS ECI IMMUNODIAGNOSTIC SYSTEM CHEMISTRY ANALYZER KHO ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other