BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 18711919 · Received February 15, 2024

    Report

    Report Number
    1319681-2024-00009
    Event Type
    Malfunction
    Date Received
    February 15, 2024
    Date of Event
    January 19, 2024
    Report Date
    February 14, 2024
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    KHO
    UDI-DI
    10758750000272
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT A LOWER THAN EXPECTED VITROS B-HCG II RESULT WAS OBTAINED WHEN VITROS REPRODUCTIVE ENDOCRINE QUALITY CONTROL FLUIDS WERE TESTED USING VITROS B-HCG II LOT 3790 ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. THE MOST LIKELY ASSIGNABLE CAUSE OF THE EVENT IS MICROWELL INCUBATOR CONTAMINATION. THE CUSTOMER STATED THAT THEIR ANALYZER WAS LOCATED NEAR THE BATHROOMS IN THEIR FACILITY, AND THAT THEY CLEAN USING CHLORINE BLEACH. PER THE VITROS ECI INSTRUCTIONS FOR USE: SOAPY WATER IS USED FOR GENERAL CLEANING; HOWEVER, A 2% SOLUTION OF FL-70 IN WATER MAY BE USED IN PLACE OF SOAPY WATER. DO NOT USE SODIUM HYPOCHLORITE, BLEACH, AMMONIA, OR ANY AMMONIA-CONTAINING COMPOUND, OR ANY OTHER OXIDIZING AGENTS TO CLEAN ANY SYSTEM COMPONENTS. SUCH USE MAY RESULT IN ERRONEOUS RESULTS AND MAY ALSO CORRODE METAL PARTS. ALTHOUGH THE CUSTOMER WAS NOT CLEANING THE ANALYZER DIRECTLY WITH BLEACH, IT IS POSSIBLE FOR THE FUMES TO LEAD TO ERRONEOUS RESULTS ON THE SYSTEM. THE CUSTOMER RELOCATED THE ANALYZER AWAY FROM THE BATHROOM AND PERFORMED THE MICROWELL INCUBATOR DECONTAMINATION PROCEDURE, AFTER WHICH THE VITROS B-HCG RESULTS RETURNED TO EXPECTATION. HISTORICAL VITROS B-HCG II LOT 3790 RESULTS FROM BIORAD QCS INDICATED ACCEPTABLE REAGENT PERFORMANCE, THEREFORE RULING OUT AN ISSUE WITH THE REAGENT LOT. ADDITIONALLY, CONTINUAL TRACKING AND TRENDING DOES NOT INDICATE A SYSTEMIC ISSUE WITH VITROS B-HCG REAGENT LOT 3790.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER THAN EXPECTED VITROS B-HCG II RESULT WAS OBTAINED WHEN VITROS REPRODUCTIVE ENDOCRINE QUALITY CONTROL FLUIDS WERE TESTED USING VITROS B-HCG II LOT 3790 ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. VITROS RE LEVEL 1 CONTROL LOT 0870 B-HCG LOT 3790 RESULT OF 4.68 VERSUS THE EXPECTED RESULT OF 10.39 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 B-HCG II RESULT WAS OBTAINED WHEN THE CUSTOMER WAS PROCESSING A NON-PATIENT FLUID. ORTHO HAS NOT BEEN MADE AWARE OF ANY 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
    1955305 VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM CHEMISTRY ANALYZER KHO ORTHO-CLINICAL DIAGNOSTICS, INC. 1922814 10758750000272

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown