BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID 19 ASSAY

    MDR report key: 11925933 · Received June 2, 2021

    Report

    Report Number
    1221359-2021-01678
    Event Type
    Malfunction
    Date Received
    June 2, 2021
    Report Date
    October 21, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REFERENCE MFR. REPORTS: 1221359-2021-01676. 1221359-2021-01677. 1221359-2021-01679. 1221359-2021-01680.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 1021882 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 190-000 / LOT 1021882, TEST BASE PART NUMBER 190-430 / LOT 1021882. 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 1021882 SHOWED THAT THE COMPLAINT RATE IS (B)(4). IN CONCLUSION, ABBOTT DIAGNOSTICS (B)(4) WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD POSSIBLY BE RELATED TO THE SPECIFIC PATIENT SAMPLE OR CROSS CONTAMINATION. REFERENCE MFR.REPORTS: 1221359-2021-01676, 1221359-2021-01677, 1221359-2021-01679, 1221359-2021-01680.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED 5 FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY AT 5 DIFFERENT LOCATIONS FOR FIVE DIFFERENT LOTS (CUMULATIVE REPORT) . THIS MFR. REPORT ADDRESSES LOT 3 OF 5. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY. THE NASAL SAMPLE WAS COLLECTED ON (B)(6) 2021. PCR CONFIRMATION TESTING (CORE LAB) ON A NASAL SAMPLE IN VIRAL TRANSPORT MEDIA COLLECTED ON (B)(6) 2021 GENERATED NEGATIVE RESULTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814565 ID NOW COVID 19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1021882 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1