BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ID NOW COVID-19 2.0 TEST KIT 24T OUS

    MDR report key: 16107461 · Received January 5, 2023

    Report

    Report Number
    1221359-2023-00042
    Event Type
    Injury
    Date Received
    January 5, 2023
    Date of Event
    December 10, 2022
    Report Date
    February 3, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 192-000. AFTER FURTHER REVIEW OF THE EVENT, IT WAS IDENTIFIED THE SAMPLE WAS STORED IN VIRAL TRANSPORT MEDIUM (VTM) PRIOR TO TESTING. THE CUSTOMER WAS ADVISED THAT PER THE PRODUCT INSTRUCTIONS FOR USE (IFU) THE ID NOW COVID-19 ASSAY IS INTENDED FOR TESTING A SWAB DIRECTLY WITHOUT ELUTION IN VIRAL TRANSPORT MEDIA. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M215322 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: M215322, TEST BASE PART NUMBER 190-430 / LOT: M215322. 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 M215322 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. SUBSTANCES IN THE SAMPLE ITSELF MAY HAVE INTERFERED WITH THE REACTION. THE CUSTOMER CONFIRMED THE SAMPLE WAS TESTED USING VTM. TESTS PERFORMED USING VTM ARE CONSIDERED OFF-LABEL USE AND ARE NOT SUPPORTED FOR USE BY ABBOTT RAPID DIAGNOSTICS SCARBOROUGH. H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.

    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 INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION OR UPON RECEIPT OF NEW INFORMATION. SINGLE USE; DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON (B)(6) 2022 ON AN UNKNOWN SAMPLE TYPE. SCREENING OF THE STRAIN WAS CONDUCTED ON (B)(6) 2022 AND WAS DETERMINED TO BE NEGATIVE FOR COVID-19. TWO (2) CONFIRMATION TESTS (GENXPERT CEPHEID AND PANTHER FUSION HOLOGIC) WERE PERFORMED ON (B)(6) 2022 (UNKNOWN SAMPLE TYPE) AND GENERATED NEGATIVE RESULTS. AN ADDITIONAL TEST WAS PERFORMED WITH THE ID NOW COVID-19 ASSAY USING THE SAME LOT ON (B)(6) 2022 (UNKNOWN SAMPLE TYPE) AND GENERATED NEGATIVE RESULTS. LASTLY, A NEW SAMPLE (UNKNOWN TYPE) WAS COLLECTED AND TESTED (PCR PANTHER FUSION HOLOGIC) ON (B)(6) 2022, ALSO GENERATING NEGATIVE RESULTS. IT WAS REPORTED THAT THE PATIENT HAS COMORBIDITIES AND WAS PLACED IN A ROOM WITH A COVID-19 POSITIVE PATIENT. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS, THE PATIENT WAS NOT INFECTED WITH COVID-19 AND SENT HOME. 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 2.0 ASSAY PERFORMED ON (B)(6) 2022 ON AN UNKNOWN SAMPLE TYPE. SCREENING OF THE STRAIN WAS CONDUCTED ON (B)(6) 2022 AND WAS DETERMINED TO BE NEGATIVE FOR COVID-19. TWO (2) CONFIRMATION TESTS (GENXPERT CEPHEID AND PANTHER FUSION HOLOGIC) WERE PERFORMED ON (B)(6) 2022 (UNKNOWN SAMPLE TYPE) AND GENERATED NEGATIVE RESULTS. AN ADDITIONAL TEST WAS PERFORMED WITH THE ID NOW COVID-19 ASSAY USING THE SAME LOT ON (B)(6) 2022 (UNKNOWN SAMPLE TYPE) AND GENERATED NEGATIVE RESULTS. LASTLY, A NEW SAMPLE (UNKNOWN TYPE) WAS COLLECTED AND TESTED (PCR PANTHER FUSION HOLOGIC) ON (B)(6) 2022, ALSO GENERATING NEGATIVE RESULTS. IT WAS REPORTED THAT THE PATIENT HAS UNKNOWN COMORBIDITIES AND WAS PLACED IN A ROOM WITH A COVID-19 POSITIVE PATIENT. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION INCLUDING PATIENT TREATMENT AND OUTCOME WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1645790 ID NOW COVID-19 2.0 TEST KIT 24T OUS REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M215322

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Other