BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 2.0 TEST KIT 24T OUS

    MDR report key: 16459750 · Received March 1, 2023

    Report

    Report Number
    1221359-2023-00413
    Event Type
    Malfunction
    Date Received
    March 1, 2023
    Date of Event
    February 22, 2023
    Report Date
    May 9, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    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. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    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. INVESTIGATION CONCLUSION: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M225109 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 M225109, TEST BASE PART NUMBER 192-430 / LOT M225109. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE.D4 - SERIAL NUMBER, B5, H6 - HEALTH IMPACT CODE H3 OTHER TEXT : OTHER - DEVICE NOT RETURNED; SINGLE USE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2023 USING NASOPHARYNGEAL DIRECT SAMPLE. THE CUSTOMER CONFIRMED TAKING TWO PCR TESTS GENERATING NEGATIVE RESULTS ON EACH. THE CUSTOMER CONFIRMED THAT THERE WAS NO IMPACT TO THE PATIENT INVOLVED DUE TO THE FALSE RESULT. NO ADDITIONAL INFORMATION, INCLUDING OUTCOME OR TREATMENT, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2023 USING NASOPHARYNGEAL DIRECT SAMPLE. THE CUSTOMER CONFIRMED TAKING TWO PCR TESTS GENERATING NEGATIVE RESULTS ON EACH. THE CUSTOMER CONFIRMED THAT THERE WAS NO IMPACT TO THE PATIENT INVOLVED DUE TO THE FALSE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143012 ID NOW COVID-19 2.0 TEST KIT 24T OUS REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M225109

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown