BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 2.0 TEST KIT 24T (EUA)

    MDR report key: 16663071 · Received April 3, 2023

    Report

    Report Number
    1221359-2023-00567
    Event Type
    Malfunction
    Date Received
    April 3, 2023
    Date of Event
    February 26, 2023
    Report Date
    June 1, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    00811877011354
    PMA / PMN Number
    EUA210517
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. DEVICE DISCARDED; SINGLE-USE DEVICE.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED IN DUPLICATE AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1093518 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 KIT PART NUMBER 192-000 / LOT 1093518 AND TEST BASE PART NUMBER 192-430 / LOT 1093518. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. THE REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED, UNCONFIRMED AND CONFLICTING RESULTS) RELATED TO KIT LOT 1093518 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 PATIENT SAMPLE INTERFERENCE AND CROSS-CONTAMINATION. SUBSTANCES IN THE SAMPLE ITSELF MAY HAVE INTERFERED WITH THE REACTION. H3 OTHER TEXT : DEVICE DISCARDED; SINGLE-USE DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED NINE (9) UNCONFIRMED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED BETWEEN (B)(6) 2023. THIS MFR. REPORT ADDRESSES TEST SEVEN (7) OF NINE (9). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON (B)(6) 2023 USING KITTED SWAB ON A NASAL SAMPLE. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED NINE (9) UNCONFIRMED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED BETWEEN (B)(6) 2023. THIS MFR. REPORT ADDRESSES TEST SEVEN (7) OF NINE (9). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON (B)(6) 2023 USING KITTED SWAB ON A NASAL SAMPLE. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1116920 ID NOW COVID-19 2.0 TEST KIT 24T (EUA) REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1093518 00811877011354

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown