BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAX NOW COVID-19 AG CARD KIT 40T EUA

    MDR report key: 18827027 · Received March 4, 2024

    Report

    Report Number
    1221359-2024-00237
    Event Type
    Malfunction
    Date Received
    March 4, 2024
    Date of Event
    February 22, 2024
    Report Date
    May 9, 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 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.

    Additional Manufacturer Narrative · 0

    D4 UDI: (B)(4). TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 227687Y 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 227687Y, TEST BASE PART NUMBER 195-430H/ LOT 223637. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD POSSIBLY BE RELATED TO ISSUES INCLUDING THE SELF-TEST USER PERFORMANCE, INTERPRETATION OF THE RESULT, OR THE SPECIFIC PATIENT SAMPLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TEN (10) FALSE POSITIVE RESULTS WITH THE BINAX NOW COVID-19 AG CARD FOR MULTIPLE PATIENTS AND STAFF MEMBERS PERFORMED FROM (B)(6) 2024 TO (B)(6) 2024. THIS MFR. REPORT ADDRESSES PATIENT AND IS TEST FOUR (4) OF TEN (10). CONFIRMATION PCR TESTING (HOLOGIC PANTHER) WAS PERFORMED ON THE SAME DAY WHICH GENERATED A NEGATIVE RESULT. THE CUSTOMER STATED THE TWO PATIENT WAS ON VANCOMYCIN. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TEN (10) FALSE POSITIVE RESULTS WITH THE BINAX NOW COVID-19 AG CARD FOR MULTIPLE PATIENTS AND STAFF MEMBERS PERFORMED FROM (B)(6) 2024. THIS MFR. REPORT ADDRESSES PATIENT AND IS TEST FOUR (4) OF TEN (10). CONFIRMATION PCR TESTING (HOLOGIC PANTHER) WAS PERFORMED ON THE SAME DAY WHICH GENERATED A NEGATIVE RESULT. THE CUSTOMER STATED THE TWO PATIENT WAS ON VANCOMYCIN. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680864 BINAX NOW COVID-19 AG CARD KIT 40T EUA CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 227687Y 10811877011290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown