BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17830786 · Received September 28, 2023

    Report

    Report Number
    1221359-2023-01449
    Event Type
    Malfunction
    Date Received
    September 28, 2023
    Date of Event
    August 9, 2023
    Report Date
    November 21, 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
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: THE DATE PROVIDED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED D4-UDI: (B)(4). INVESTIGATION RESULTS: TESTING WAS PERFORMED IN DUPLICATE AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M233342 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 M233342 AND TEST BASE PART NUMBER 192-430/ LOT M233342. 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 M233342 SHOWED THAT THE COMPLAINT RATE IS (B)(4). A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M233342 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUES AS LOGFILES WERE NOT PROVIDED; HOWEVER, A POSSIBLE ASSIGNABLE ROOT CAUSE FOR FALSE POSITIVE AND NEGATIVE RESULTS IS PATIENT SAMPLE INTERFERENCE. SUBSTANCES IN THE SAMPLE ITSELF MAY HAVE INTERFERED WITH THE REACTION. H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    B3: THE DATE PROVIDED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED D4-UDI:(B)(4). THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CUSTOMER QUESTIONED THE VALIDITY OF AN UNKNOWN QUANTITY OF PATIENT RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON OR BEFORE (B)(6) 2023. NO ADDITIONAL TEST INFORMATION, INCLUDING IF THE PATIENT RESULTS WERE FALSE POSITIVE OR NEGATIVE RESULTS, WAS PROVIDED. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER QUESTIONED THE VALIDITY OF AN UNKNOWN QUANTITY OF PATIENT RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON OR BEFORE (B)(6) 2023. NO ADDITIONAL TEST INFORMATION, INCLUDING IF THE PATIENT RESULTS WERE FALSE POSITIVE OR NEGATIVE RESULTS, WAS PROVIDED. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1553378 ID NOW COVID-19 2.0 TEST KIT 24T (EUA) REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M233342 00811877011354

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown