BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 2.0 TEST KIT 24T OUS

    MDR report key: 19512721 · Received June 11, 2024

    Report

    Report Number
    1221359-2024-00419
    Event Type
    Malfunction
    Date Received
    June 11, 2024
    Date of Event
    May 6, 2024
    Report Date
    July 3, 2024
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QWR
    UDI-DI
    00811877011378
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: D2A - COMMON DEVICE NAME, D2B - PROCODE 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 193-000 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 M807001 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 193-000 / LOT M807001, TEST BASE PART NUMBER 192-430 / LOT M807001. 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 M807001 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 COULD BE PATIENT SAMPLE INTERFERENCE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 193-000 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 192-000. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED UNKNOWN NUMBER OF FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON (B)(6) 2024 AND (B)(6) 2024 INVOLVING UNKNOWN NUMBER OF PATIENTS. THIS MFR. REPORT ADDRESSES RESULT TWO (2) OF TWO (2). NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED UNKNOWN NUMBER OF FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON (B)(6) 2024 INVOLVING UNKNOWN NUMBER OF PATIENTS. THIS MFR. REPORT ADDRESSES RESULT TWO (2) OF TWO (2). NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602211 ID NOW COVID-19 2.0 TEST KIT 24T OUS SIMPLE POINT-OF-CARE DEVICE TO DETECT SAR-COV-2 NUCLEIC ACID TARGETS QWR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M807001 00811877011378
    814960 ID NOW COVID-19 2.0 TEST KIT 24T OUS SIMPLE POINT-OF-CARE DEVICE TO DETECT SAR-COV-2 NUCLEIC ACID TARGETS QWR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M807001 00811877011378

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown