BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15969033 · Received December 13, 2022

    Report

    Report Number
    1221359-2022-10306
    Event Type
    Malfunction
    Date Received
    December 13, 2022
    Date of Event
    November 18, 2022
    Report Date
    March 16, 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
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1090429 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 1090429 AND TEST BASE PART NUMBER 192-430 / LOT 1090429. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 1090429 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. H3 OTHER TEXT : SINGLE USE DEVICE, DISCARDED.

    Additional Manufacturer Narrative · 0

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENT REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED WITH A NASAL SWAB SAMPLE ON 18NOV2022. CONFIRMATION TESTING (PLATFORM: DIASORIN) WAS PERFORMED ON A NASOPHARYNGEAL SWAB SAMPLE, COLLECTED ON 18NOV2022 IN VIRAL TRANSPORT MEDIUM, GENERATED A POSITIVE RESULT. PER THE CUSTOMER, NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED WITH A NASAL SWAB SAMPLE ON (B)(6) 2022. CONFIRMATION TESTING (PLATFORM: DIASORIN) WAS PERFORMED ON A NASOPHARYNGEAL SWAB SAMPLE, COLLECTED ON (B)(6) 2022 IN VIRAL TRANSPORT MEDIUM, GENERATED A POSITIVE RESULT. PER THE CUSTOMER, NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386702 ID NOW COVID-19 2.0 TEST KIT 24T (EUA) REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1090429 00811877011354

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown