BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 2.0 TEST KIT 24T JAPAN

    MDR report key: 19928865 · Received August 7, 2024

    Report

    Report Number
    1221359-2024-00537
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    July 31, 2024
    Report Date
    October 14, 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 - COMMON DEVICE NAME: SIMPLE POINT-OF-CARE DEVICE TO DETECT SAR-COV-2 NUCLEIC ACID TARGETS FROM CLINICAL SPECIMENS IN NEAR-PATIENT SETTINGS G4 - 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 RESULTS OF THE INVESTIGATION ARE STILL PENDING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OR UPON RECEIPT OF ADDITIONAL INFORMATION.

    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 - 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 M834731 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 KIT PART NUMBER 192-000J / LOT M834731 AND TEST BASE PART NUMBER 192-430 / LOT M834731. 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 M834731 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, POSSIBLE ASSIGNABLE ROOT CAUSES ARE PATIENT SAMPLE INTERFERENCE AND CONTAMINATION. SUBSTANCES IN THE SAMPLE ITSELF MAY HAVE INTERFERED WITH THE REACTION.

    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 - 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 M834731 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 KIT PART NUMBER 192-000J / LOT M834731 AND TEST BASE PART NUMBER 192-430 / LOT M834731. 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 M834731 SHOWED THAT THE COMPLAINT RATE IS (B)(4)%. ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. CORRECTION: G1 - CONTACT OFFICE FAX NUMBER NULL: NA.

    Description of Event or Problem · 0

    THE CUSTOMER CALLED TO REPORT FALSE POSITIVE RESULTS FOR TWO (2) PATIENTS WITH THE ID NOW COVID-19 2.0 TEST KIT ON 31 JUL 2024. THIS REPORT IS FOR PATIENT ONE (1) OF TWO (2). CONFIRMATORY PCR TESTING (PLATFORM UNKNOWN) WAS PERFORMED 31 JUL 2024 WHICH GENERATED A NEGATIVE RESULT. THE CUSTOMER INDICATED THAT NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER CALLED TO REPORT FALSE POSITIVE RESULTS FOR TWO (2) PATIENTS WITH THE ID NOW COVID-19 2.0 TEST KIT ON (B)(6) 2024. THIS REPORT IS FOR PATIENT ONE (1) OF TWO (2). CONFIRMATORY PCR TESTING (PLATFORM UNKNOWN) WAS PERFORMED ON (B)(6) 2024 WHICH GENERATED A NEGATIVE RESULT. THE CUSTOMER INDICATED THAT NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER CALLED TO REPORT FALSE POSITIVE RESULTS FOR TWO (2) PATIENTS WITH THE ID NOW COVID-19 2.0 TEST KIT ON (B)(6) 2024. THIS REPORT IS FOR PATIENT ONE (1) OF TWO (2). CONFIRMATORY PCR TESTING (PLATFORM UNKNOWN) WAS PERFORMED (B)(6) 2024 WHICH GENERATED A NEGATIVE RESULT. THE CUSTOMER INDICATED THAT NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534575 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. M834731 04571226475447

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown