BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 14190115 · Received April 22, 2022

    Report

    Report Number
    1221359-2022-02112
    Event Type
    Malfunction
    Date Received
    April 22, 2022
    Date of Event
    March 12, 2022
    Report Date
    November 28, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC
    Product Code
    QJR
    UDI-DI
    10811877011320
    PMA / PMN Number
    EUA210264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS . A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REFERENCE MFR. REPORTS: 1221359-2022-02111.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M173879 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST KIT PART NUMBER 191-000 / LOT M173879, TEST BASE PART NUMBER 190-430 / LOT M173879. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M173879 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE AS THE LOGFILES WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE CORRECTIONS TO THE PREVIOUSLY REPORTED EVENT. PLEASE SEE UPDATES: D9, E3, G1, G4, G6 AND H2. CORRECTED DATA: G3- SUPPLEMENTAL REPORT 1 DATE RECEIVED BY MANUFACTURER :15-NOV-2021.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TWO FALSE POSITIVE RESULTS WITH ID NOW COVID-19 .THE SECOND TEST WAS PERFORMED ON (B)(6) 2022. CONFIRMATION TESTING WAS PERFORMED ON (B)(6) 2022, AND GENERATED NEGATIVE RESULT . NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED. NO INFORMATION WAS PROVIDED IF PATIENT WAS ASYMPTOMATIC OR SYMPTOMATIC . THIS MFR. REPORT ADDRESSES TEST TWO (2) OF TWO (2) TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183818 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC M173879 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Female