BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 2.0 TEST KIT 24T CANADA

    MDR report key: 21403025 · Received February 18, 2025

    Report

    Report Number
    1221359-2025-00055
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    February 5, 2025
    Report Date
    May 12, 2025
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QWR
    UDI-DI
    00811877011583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2A - COMMON DEVICE NAME: SIMPLE POINT-OF-CARE DEVICE TO DETECT SAR-COV-2 NUCLEIC ACID TARGETS FROM CLINICAL SPECIMENS IN NEAR-PATIENT SETTINGS G4 - PMA/510(K) #: THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 193-000C THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 192-000. THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 0

    D2A - COMMON DEVICE NAME: SIMPLE POINT-OF-CARE DEVICE TO DETECT SAR-COV-2 NUCLEIC ACID TARGETS FROM CLINICAL SPECIMENS IN NEAR-PATIENT SETTINGS. G4 - PMA/510(K) #: THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 193-000C THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 192-000. CORRECTION: H10 - RELATED REPORT NUMBERS: NA TO BLANK. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT NUMBER M851262 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 193-000C / LOT M851262 AND DEVICE PART NUMBER 192-430 / LOT M851262. 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 M851262 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. HOWEVER, A POSSIBLE ASSIGNABLE ROOT CAUSE IS PATIENT SAMPLE INTERFERENCE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON (B)(6) 2025HOURS WITH A NASOPHARYNGEAL SAMPLE. THE CUSTOMER SUBMITTED A PATIENT SAMPLE FOR PCR TESTING AND RECEIVED A NEGATIVE RESULT FOR COVID-19. THERE WAS NO CLINICAL IMPACT REPORTED AS A RESULT OF THE EVENT. THE PATIENT WAS ISOLATED BASED ON THEIR SYMPTOMS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON (B)(6) 2025 AT 1728 HOURS WITH A NASOPHARYNGEAL SAMPLE. THE CUSTOMER SUBMITTED A PATIENT SAMPLE FOR PCR TESTING AND RECEIVED A NEGATIVE RESULT FOR COVID-19. THERE WAS NO CLINICAL IMPACT REPORTED AS A RESULT OF THE EVENT. THE PATIENT WAS ISOLATED BASED ON THEIR SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2670546 ID NOW COVID-19 2.0 TEST KIT 24T CANADA SIMPLE POINT-OF-CARE DEVICE TO DETECT SAR-COV-2 NUCLEIC ACID TARGETS QWR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M851262 00811877011583

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown