BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 15723191 · Received November 3, 2022

    Report

    Report Number
    1221359-2022-05250
    Event Type
    Malfunction
    Date Received
    November 3, 2022
    Date of Event
    October 27, 2022
    Report Date
    February 2, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION REPORT: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M212946 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 BASE PART NUMBER 190-430 / LOT M212946. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE AND FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 172637 SHOWED THAT THE COMPLAINT RATE IS (B)(4) % RESPECTIVELY. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. HOWEVER, A POSSIBLE ASSIGNABLE ROOT CAUSE IS PATIENT SAMPLE INTERFERENCE.

    Additional Manufacturer Narrative · 0

    DEVICE INFORMATION: SIMILAR PRODUCT TO 190-000. THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A CONFLICTING RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2022. THE PATIENT TESTED POSITIVE WITH THE ID NOW COVID-19 ASSAY AND GENERATED A POSITIVE RESULT. RETESTING WAS PERFORMED ON THE SAME DAY WITH THE ID NOW COVID-19 ASSAY AND GENERATED A NEGATIVE RESULT. NASOPHARYNGEAL SWAB WAS USED FOR BOTH TESTS. THE PATIENT REPORTEDLY HAD FEVER. 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
    522121 ID NOW COVID-19 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M212946

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown