BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 14237303 · Received April 28, 2022

    Report

    Report Number
    1221359-2022-02396
    Event Type
    Malfunction
    Date Received
    April 28, 2022
    Date of Event
    April 5, 2022
    Report Date
    May 25, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION REPORT: TESTING WAS PERFORMED IN DUPLICATE AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M181422 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 M181422, DEVICE PART NUMBER 190-430 / LOT M181422. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M181422 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE HOWEVER, A POSSIBLE ASSIGNABLE ROOT CAUSE IS PATIENT SAMPLE INTERFERENCE. SUBSTANCES IN THE SAMPLE ITSELF MAY HAVE INTERFERED WITH THE REACTION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2022. ON AN UNKNOWN SAMPLE TYPE. CONFIRMATION TESTING (PLATFORM: UNKNOWN) VIA PCR WAS PERFORMED AND GENERATED NEGATIVE RESULTS. THE CUSTOMER STATED NO FURTHER INFORMATION WOUDL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205180 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M181422 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown