BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 7103824 · Received December 11, 2017

    Report

    Report Number
    1319681-2017-00119
    Event Type
    Malfunction
    Date Received
    December 11, 2017
    Date of Event
    November 13, 2017
    Report Date
    December 11, 2017
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KHO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A LOWER THAN EXPECTED TROPONIN I RESULT WAS OBTAINED FROM A CLINIQA LOT 1705191 QUALITY CONTROL SAMPLE PROCESSED USING VITROS TROPONIN I ES REAGENT WITH A VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT IS AN INSTRUMENT RELATED ISSUE DUE TO USER ERROR. IT IS LIKELY THAT INSUFFICIENT DAILY MAINTENANCE CONTRIBUTED TO THE LOWER THAN EXPECTED TROPONIN I RESULT AS SIGNAL REAGENT CRYSTALS WERE OBSERVED ON THE SIGNAL REAGENT PROBES AS A RESULT OF THE PROBES NOT BEING CLEANED PER DAILY INSTRUMENT MAINTENANCE. SIGNAL REAGENT CONTAMINATION CAN CAUSE A SUPPRESSION OF THE WELL SIGNAL CAUSING A LOWER THAN EXPECTED RESULT FOR AN IMMUNOMETRIC ASSAY SUCH AS VITROS TROPI ES. THE ORTHO FIELD ENGINEER PERFORMED CLEANING AND MAINTENANCE ACTIONS TO MULTIPLE ANALYZER SUBSYSTEMS AND FOLLOWING THOSE ACTIONS ACCEPTABLE CLINIQA QC RESULTS WERE OBTAINED, INDICATING THE VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM WAS PERFORMING AS EXPECTED. THE CUSTOMER ONLY PROVIDED QC FLUID DATA FROM THE DAY OF THE EVENT SO IT WAS NOT POSSIBLE TO ASSESS THE PERFORMANCE OF VITROS TROPI ES LOT 2550 AT THE CUSTOMER SITE. NEVERTHELESS, THE CUSTOMER DOES NOT PROCESS A CONTROL FLUID WITH A TROPONIN I CONCENTRATION AT, OR BELOW THE URL. THEREFORE, THE PERFORMANCE OF THE VITROS TROPI ES REAGENT LOT 2550 AT, OR BELOW THE URL CONCENTRATION OF 0.034 NG/ML, CANNOT BE DETERMINED AND A REAGENT ISSUE COULD NOT BE ENTIRELY RULED OUT AS CONTRIBUTING TO THE EVENT.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED A LOWER THAN EXPECTED TROPONIN I RESULT FROM A CLINIQA LOT 1705191 QUALITY CONTROL FLUID (LEVEL 1= 0.019 NG/ML VS. EXPECTED 0.080 NG/ML) USING VITROS TROPONIN I ES REAGENT IN COMBINATION WITH A VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE UNEXPECTED VITROS TROPONIN I RESULT WAS GENERATED FROM A NON-PATIENT FLUID, HOWEVER THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WERE NOT AFFECTED OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883307 VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM IMMUNODIAGNOSTIC SYSTEM KHO ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1