BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARS-COV-2 IGG

    MDR report key: 10202415 · Received June 26, 2020

    Report

    Report Number
    1415939-2020-00062
    Event Type
    Malfunction
    Date Received
    June 26, 2020
    Date of Event
    May 27, 2020
    Report Date
    July 30, 2020
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    QKO
    UDI-DI
    00380740192150
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. PATIENT IDENTIFIER: COMPLETE SID'S: FOR 1ST PATIENT: (B)(6); 2ND PATIENT SID = (B)(6).

    Additional Manufacturer Narrative · 1

    THE COMPLAINT INVESTIGATION FOR FALSELY POSITIVE RESULTS INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, AND THE REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELLING, SCIENTIFIC LITERATURE AND DEVICE HISTORY RECORDS. RETURN SAMPLES WERE TESTED AND ALIGNED WITH THE RESULTS OBTAINED BY THE CUSTOMER. PERFORMANCE TESTING FOR REAGENT LOT 16020M800 WAS COMPLETED. DEVICE HISTORY RECORD REVIEW ON LOT 16020M800 DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, OR DEVIATIONS. LABELLING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. PERFORMANCE SPECIFICITY TESTING USING A RETAINED SAMPLE OF THE COMPLAINT LOT INDICATES THAT THE LOT IS PERFORMING ACCEPTABLY. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT SARS-COV-2 IGG REAGENT LOT 16020M800 WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE POSITIVE ARCHITECT SARS-COV-2 IGG ON A (B)(6) YR OLD ASYMPTOMATIC WHITE MALE PATIENT. RESULTS PROVIDED: ON (B)(6) 2020 SID (B)(6) = 4.13 / 4.09 INDEX (> OR = 1.4 INDEX IS POSITIVE), SAME SAMPLE RUN ON (B)(6) 2020 BY HAMA = 4.03 S/CO; NEW SAMPLE ON (B)(6) 2020 SID (B)(6) = 4.02 INDEX; ON (B)(6) 2020 ON BECKMAN ACCESS = 0.01 S/CO (NEGATIVE), EDI NOVEL CORONAVIRUS COVID-19 IGG ELISA = 0.17 OD (NEGATIVE). ADDITIONAL ASYMPTOMATIC PATIENT SID (B)(6) = 2.29 / 2.23 INDEX, BECKMAN ACCESS = 0.02 S/CO (NEGATIVE), ELIZA EDA = 0.160 O/D (NEGATIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665762 SARS-COV-2 IGG COV-2 IGG QKO ABBOTT LABORATORIES 06R8630 16020M800 00380740192150

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR