BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17883325 · Received October 6, 2023

    Report

    Report Number
    1221359-2023-01507
    Event Type
    Malfunction
    Date Received
    October 6, 2023
    Date of Event
    September 28, 2023
    Report Date
    December 4, 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
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4 UDI: (B)(4). DATE OF EVENT PROVIDED IN SECTION B3 IS AN APPROXIMATION, WAS NOT PROVIDED BY CONSUMER. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M233067 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 M233067, TEST BASE PART NUMBER 192-430/ LOT M233067. 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 M233067 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, HOWEVER IT COULD HAVE POSSIBLY BEEN RELATED TO THE SPECIFIC PATIENT SAMPLE. H3 OTHER TEXT : SINGLE-USE, DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    D4 UDI: (B)(4). DATE OF EVENT PROVIDED IN SECTION B3 IS AN APPROXIMATION, WAS NOT PROVIDED BY CONSUMER. THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION OR UPON RECEIPT OF NEW INFORMATION. H3 OTHER TEXT : SINGLE-USE, DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THIRTY-ONE (31) UNCONFIRMED AND ONE (1) CONFIRMED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 2.0 TEST KIT FOR MULTIPLE PATIENTS PERFORMED ON DIFFERENT DAYS. THIS MFR. REPORT ADDRESSES UNCONFIRMED FALSE POSITIVE RESULT AND IS PATIENT FIFTEEN (15) OF THIRTY-TWO (32). THE CONSUMER DID NOT REPORT IF ANY REPEAT OR CONFIRMATION TESTING WAS PERFORMED. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THIRTY-ONE (31) UNCONFIRMED AND ONE (1) CONFIRMED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 2.0 TEST KIT FOR MULTIPLE PATIENTS PERFORMED ON DIFFERENT DAYS. THIS MFR. REPORT ADDRESSES UNCONFIRMED FALSE POSITIVE RESULT AND IS PATIENT FIFTEEN (15) OF THIRTY-TWO (32). THE CONSUMER DID NOT REPORT IF ANY REPEAT OR CONFIRMATION TESTING WAS PERFORMED. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1270563 ID NOW COVID-19 2.0 TEST KIT 24T (EUA) REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M233067 00811877011354

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown