BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAX NOW COVID-19 AG CARD KIT 40T EUA

    MDR report key: 18427726 · Received January 2, 2024

    Report

    Report Number
    1221359-2024-00002
    Event Type
    Malfunction
    Date Received
    January 2, 2024
    Date of Event
    December 4, 2023
    Report Date
    March 19, 2024
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    10811877011290
    PMA / PMN Number
    EUA202537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI (B)(4). THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. H3 OTHER TEXT : OTHER - DEVICE NOT RETURNED; SINGLE USE DEVICE.

    Additional Manufacturer Narrative · 0

    D4: UDI (B)(4). THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.PLEASE SEE THE FIELD FOR CORRECTIONS: B5 H3 OTHER TEXT : OTHER - DEVICE NOT RETURNED; SINGLE USE DEVICE.

    Additional Manufacturer Narrative · 0

    D4: UDI (B)(4). TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 229039X 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 195-000 / LOT 229039X, TEST BASE PART NUMBER 195-430H / LOT 225032R. 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 229039X SHOWED THAT THE COMPLAINT RATE IS (B)(4).. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. DEVICE NOT RETURNED; SINGLE USE DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THREE (3) FALSE POSITIVE RESULTS USING BINAX NOW COVID-19 AG CARD KIT BETWEEN 04DEC2023 TO 12DEC2023 WITH NASAL SWABS. THIS REPORT IS FOR TEST ONE (1) OF THREE (3). ON (B)(6) 2023 THE USER DESCRIBED GETTING A FAINT GRAY/PURPLE LINE IN THE SAMPLE REGION. ADDITIONAL TESTING WAS PERFORMED WITH HOLOGIC PANTHER MOLECULAR, GENERATING A NEGATIVE RESULT. NO ADDITIONAL INFORMATION, INCLUDING PATIENT OUTCOME OR TREATMENT, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED SIX (6) FALSE RESULTS USING BINAX NOW COVID-19 AG CARD KIT BETWEEN (B)(6) 2023 WITH NASAL SWABS. THIS REPORT IS FOR TEST ONE (1) OF SIX (6). ON (B)(6) 2023 THE USER DESCRIBED GETTING A FAINT GRAY/PURPLE LINE IN THE SAMPLE REGION. ADDITIONAL TESTING WAS PERFORMED WITH HOLOGIC PANTHER MOLECULAR, GENERATING A NEGATIVE RESULT. NO ADDITIONAL INFORMATION, INCLUDING PATIENT OUTCOME OR TREATMENT, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED SIX (6) FALSE RESULTS USING BINAX NOW COVID-19 AG CARD KIT BETWEEN 04DEC2023 TO 12DEC2023 WITH NASAL SWABS. THIS REPORT IS FOR TEST ONE (1) OF SIX (6). ON 04DEC2023 THE USER DESCRIBED GETTING A FAINT GRAY/PURPLE LINE IN THE SAMPLE REGION. ADDITIONAL TESTING WAS PERFORMED WITH HOLOGIC PANTHER MOLECULAR, GENERATING A NEGATIVE RESULT. NO ADDITIONAL INFORMATION, INCLUDING PATIENT OUTCOME OR TREATMENT, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1419189 BINAX NOW COVID-19 AG CARD KIT 40T EUA CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 229039X 10811877011290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown