BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-SARS-COV-2 IGG REAGENT PACK

    MDR report key: 11313682 · Received February 11, 2021

    Report

    Report Number
    3007111389-2021-00023
    Event Type
    Malfunction
    Date Received
    February 11, 2021
    Date of Event
    July 17, 2020
    Report Date
    February 11, 2021
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    QKO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT DISCORDANT REACTIVE VITROS ANTI-SARS-COV-2 IGG (COV2IGG) RESULTS WERE OBTAINED FROM A PATIENT SAMPLE PROCESSED ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. THE VITROS COV2IGG RESULTS WERE DISCORDANT BASED ON NON-REACTIVE VITROS ANTI-SARS-COV-2 TOTAL (COV2TOT) RESULTS OBTAINED FROM THE SAME PATIENT SAMPLE. A DEFINITIVE ASSIGNABLE CAUSE FOR THE DISCORDANT REACTIVE RESULTS COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. THE PATIENT WAS AN EMPLOYEE THAT WAS TESTED PER REGULAR EMPLOYEE SCREENING AND WAS ASYMPTOMATIC. NO ADDITIONAL TESTING TO DETECT THE PRESENCE OF AN INTERFERENT WAS PERFORMED ON THE PATIENT SAMPLE. IN ADDITION, DIRECT TESTING FOR VIRUS (E.G., PCR TESTING) SHOULD ALWAYS BE PERFORMED IN ANY INDIVIDUAL SUSPECTED OF COVID-19, REGARDLESS OF THE VITROS COV2TOT OR VITROS COV2IGG TEST RESULTS. HOWEVER, PCR TESTING WAS NOT PERFORMED ON THE PATIENT BEFORE OR AFTER THE VITROS ANTIBODY TESTING WAS COMPLETED. IT WAS CONCLUDED THAT THE DISCORDANCY BETWEEN THE VITROS COV2IGG AND COV2TOT ASSAYS WAS DUE TO FALSE POSITIVE COV2IGG RESULTS FOR THE PATIENT SAMPLE. THE VITROS COV2IGG INSTRUCTIONS FOR USE DOES NOT PRECLUDE THE POSSIBILITY OF FALSE POSITIVE COV2IGG RESULTS DUE TO CROSS-REACTIVITY FROM PRE-EXISTING ANTIBODIES OR OTHER POSSIBLE CAUSES. THE CUSTOMER DID NOT PROVIDE VITROS COV2IGG QUALITY CONTROL RESULTS. THEREFORE, IT CANNOT BE CONFIRMED IF THE ASSAY WAS PERFORMING AS EXPECTED AND A VITROS COV2IGG REAGENT LOT 0160 ISSUE CANNOT BE RULED OUT AS A POTENTIAL CONTRIBUTOR TO THE EVENT. ONGOING TRACKING AND TRENDING OF COMPLAINT DATA HAS NOT IDENTIFIED ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH THE VITROS COV2IGG REAGENT LOT 0160. THERE WAS NO INDICATION OF ANY INSTRUMENT MALFUNCTION AND UNEXPECTED INSTRUMENT PERFORMANCE WAS NOT A LIKELY CONTRIBUTOR TO THE EVENT. THE CUSTOMER PROVIDED NO INFORMATION CONCERNING THE SAMPLE COLLECTION DEVICE USED TO COLLECT THE AFFECTED SAMPLE OR SAMPLE PROCESSING OF THE AFFECTED SAMPLE. THEREFORE, PRE-ANALYTICAL SAMPLE HANDLING CANNOT BE RULED OUT AS A POTENTIAL CONTRIBUTOR TO THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED DISCORDANT REACTIVE VITROS ANTI-SARS-COV-2 IGG (COV2IGG) RESULTS OBTAINED FROM A PATIENT SAMPLE PROCESSED ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. THE VITROS COV2IGG RESULTS WERE DISCORDANT BASED ON NON-REACTIVE VITROS ANTI-SARS-COV-2 TOTAL (COV2TOT) RESULTS OBTAINED FROM THE SAME PATIENT SAMPLE. PATIENT SAMPLE VITROS ANTI-SARS-COV-2 IGG RESULTS OF REACTIVE (2.98, 3.03 S/C) VERSUS EXPECTED RESULTS OF NON-REACTIVE BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE EMPLOYEE (PATIENT) WAS INFORMED THAT THEY WERE COVID ANTIBODY POSITIVE. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216428 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-SARS-COV-2 IGG REAGENT PACK IN VITRO DIAGNOSTICS QKO ORTHO-CLINICAL DIAGNOSTICS 0160

    Patients

    Seq Age Sex Outcome Treatment
    1