BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 2.0 TEST KIT 24T JAPAN

    MDR report key: 19668219 · Received July 3, 2024

    Report

    Report Number
    1221359-2024-00446
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    June 28, 2024
    Report Date
    August 19, 2024
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QWR
    UDI-DI
    04571226475447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2A: SIMPLE POINT-OF-CARE DEVICE TO DETECT SAR-COV-2 NUCLEIC ACID TARGETS FROM CLINICAL SPECIMENS IN NEAR-PATIENT SETTINGS. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 192-000J 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 OR UPON RECEIPT OF NEW INFORMATION.

    Additional Manufacturer Narrative · 0

    D2A: SIMPLE POINT-OF-CARE DEVICE TO DETECT SAR-COV-2 NUCLEIC ACID TARGETS FROM CLINICAL SPECIMENS IN NEAR-PATIENT SETTINGS THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 192-000J THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 192-000. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M832759 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 192-000J/LOT M832759, TEST BASE PART NUMBER 192-430/ LOT M832759. 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 M832759 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, HOWEVER IT COULD HAVE POSSIBLY BEEN RELATED TO UNKNOWN INTERFERENCE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 2.0 TEST KIT PERFORMED ON (B)(6) 2024 ON A NASOPHARYNGEAL SAMPLE. ADDITIONAL TESTING WAS PERFORMED ON THE SAME DAY WITH AN ANTIGEN TEST KIT (PLATFORM - UNKNOWN) WHICH GENERATED A NEGATIVE RESULT. CONFIRMATORY PCR TESTING WAS PERFORMED ON THE SAME DAY WHICH GENERATED A NEGATIVE RESULT. THE CUSTOMER STATED THAT THE PATIENT WAS NEGATIVE BEFORE THE FALSE POSITIVE RESULT. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 2.0 TEST KIT PERFORMED ON (B)(6) 2024 ON A NASOPHARYNGEAL SAMPLE. ADDITIONAL TESTING WAS PERFORMED ON THE SAME DAY WITH AN ANTIGEN TEST KIT (PLATFORM - UNKNOWN) WHICH GENERATED A NEGATIVE RESULT. CONFIRMATORY PCR TESTING WAS PERFORMED ON THE SAME DAY WHICH GENERATED A NEGATIVE RESULT. THE CUSTOMER STATED THAT THE PATIENT WAS NEGATIVE BEFORE THE FALSE POSITIVE RESULT. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478326 ID NOW COVID-19 2.0 TEST KIT 24T JAPAN SIMPLE POINT-OF-CARE DEVICE TO DETECT SAR-COV-2 NUCLEIC ACID TARGETS QWR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M832759 04571226475447

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown