BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 TEST KIT 24T (OUS)

    MDR report key: 16292236 · Received February 3, 2023

    Report

    Report Number
    1221359-2023-00209
    Event Type
    Malfunction
    Date Received
    February 3, 2023
    Date of Event
    February 1, 2023
    Report Date
    August 10, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 190-000. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M147962 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 191-000 / LOT M147962 AND TEST BASE PART NUMBER 190-430 / LOT M147962. 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 M147962 SHOWED THAT THE COMPLAINT RATE IS 0.00183%. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. HOWEVER, A POSSIBLE ASSIGNABLE ROOT CAUSE IS SAMPLE INTERFERENCE OR CROSS CONTAMINATION. H3 OTHER TEXT : OTHER - DEVICE NOT RETURNED; SINGLE USE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 191-000 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 190-000. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M147962 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 191-000 / LOT M147962 AND TEST BASE PART NUMBER 190-430 / LOT M147962. 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 M147962 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 SAMPLE INTERFERENCE OR CROSS CONTAMINATION. PLEASE SEE FIELDS FOR APPROPRIATE CORRECTIONS: D5, E1-COUNTRY AND H10 H3 OTHER TEXT : OTHER - DEVICE NOT RETURNED; SINGLE USE.

    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 190-000. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. DEVICE NOT RETURNED; SINGLE USE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT USING ID NOW COVID-19 ASSAY PERFORMED USING AN UNKNOWN SAMPLE TYPE. NO REPEAT CONFIRMATION TESTING WAS PROVIDED AT THE TIME OF THIS REPORT. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION, INCLUDING PATIENT OUTCOME OR TREATMENT, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT USING ID NOW COVID-19 ASSAY PERFORMED USING AN UNKNOWN SAMPLE TYPE. NO REPEAT CONFIRMATION TESTING WAS PROVIDED AT THE TIME OF THIS REPORT. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION, INCLUDING PATIENT OUTCOME OR TREATMENT, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT USING ID NOW COVID-19 ASSAY PERFORMED USING AN UNKNOWN SAMPLE TYPE. NO REPEAT CONFIRMATION TESTING WAS PROVIDED AT THE TIME OF THIS REPORT. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION, INCLUDING PATIENT OUTCOME OR TREATMENT, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175543 ID NOW COVID-19 TEST KIT 24T (OUS) REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown