BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 TEST KIT 24T JP

    MDR report key: 16781332 · Received April 20, 2023

    Report

    Report Number
    1221359-2023-00648
    Event Type
    Malfunction
    Date Received
    April 20, 2023
    Date of Event
    April 7, 2023
    Report Date
    June 12, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4 - LOT NUMBER: CUSTOMER WAS UNSURE OF EXACT LOT NUMBER, EXPRESSED THE POSSIBILITY THAT IT WAS LOT M213568. LOT INFORMATION BELOW: D4 - EXPIRATION DATE: 12MAY2023; H4 - DEVICE MANUFACTURE DATE: 14AUG2022. THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    D4 - LOT NUMBER: CUSTOMER WAS UNSURE OF EXACT LOT NUMBER, EXPRESSED THE POSSIBILITY THAT IT WAS LOT M213568. LOT INFORMATION BELOW: D4 - EXPIRATION DATE: 12MAY2023; H4 - DEVICE MANUFACTURE DATE: 14AUG2022 TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M213568 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 190-000J / LOT M213568, TEST BASE PART NUMBER 190-430 / LOT M213568. 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 M213568 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, A POSSIBLE ASSIGNABLE ROOT CAUSE IS PATIENT SAMPLE INTERFERENCE. COMPLAINTS AGAINST THESE TREND CODES ARE MONITORED TO IDENTIFY AND TRACK ANY OUT-OF-TREND/UNEXPECTED PERFORMANCE AT THE LOT AND PRODUCT FAMILY LEVEL. H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2023 ON AN UNKNOWN SAMPLE TYPE. AN ANTIGEN TEST (BRAND UNKNOWN) WAS ALSO PERFORMED AND GENERATED NEGATIVE RESULTS. AFTER 30 MINUTES, AN ADDITIONAL TEST WITH THE ID NOW COVID-19 ASSAY WAS PERFORMED AND GENERATED NEGATIVE RESULTS. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2023 ON AN UNKNOWN SAMPLE TYPE. AN ANTIGEN TEST (BRAND UNKNOWN) WAS ALSO PERFORMED AND GENERATED NEGATIVE RESULTS. AFTER 30 MINUTES, AN ADDITIONAL TEST WITH THE ID NOW COVID-19 ASSAY WAS PERFORMED AND GENERATED NEGATIVE RESULTS. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1590478 ID NOW COVID-19 TEST KIT 24T JP REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown