BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16108590 · Received January 5, 2023

    Report

    Report Number
    1221359-2023-00044
    Event Type
    Malfunction
    Date Received
    January 5, 2023
    Date of Event
    December 27, 2022
    Report Date
    March 20, 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
    TX, 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 1092961 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 192-000 / LOT 1092961, TEST BASE PART NUMBER 192-430 / LOT 1092961. 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 1092961 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FOUR (4) UNCONFIRMED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 2.0 FOR MULTIPLE PATIENTS PERFORMED ON MULTIPLE DATES. THIS MFR. REPORT ADDRESSES TEST/PATIENT THREE (3) OF FOUR (4). THE CUSTOMER SELF-REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 2.0 PERFORMED ON (B)(6) 2022 ON A NASAL SWAB. CONFIRMATION TESTING WAS NOT PERFORMED. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THEIR TREATMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FOUR (4) UNCONFIRMED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 2.0 FOR MULTIPLE PATIENTS PERFORMED ON MULTIPLE DATES. THIS MFR. REPORT ADDRESSES TEST/PATIENT THREE (3) OF FOUR (4). THE CUSTOMER SELF-REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 2.0 PERFORMED ON (B)(6) 2022 ON A NASAL SWAB. CONFIRMATION TESTING WAS NOT PERFORMED. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THEIR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186242 ID NOW COVID-19 2.0 TEST KIT 24T (EUA) REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1092961 00811877011354

    Patients

    Seq Age Sex Outcome Treatment
    1 Female