BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAX NOW COVID-19 AG CARD KIT 40T EUA

    MDR report key: 19639126 · Received June 28, 2024

    Report

    Report Number
    1221359-2024-00435
    Event Type
    Malfunction
    Date Received
    June 28, 2024
    Date of Event
    April 1, 2024
    Report Date
    July 23, 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

    H11 - B3: THE DATE INDICATED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED. 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 AND TEST BASE PART NUMBER 195-430H/ LOT 223637. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 227687Y 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.

    Additional Manufacturer Narrative · 0

    H11 - B3: THE DATE INDICATED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION OR UPON RECEIPT OF NEW INFORMATION.

    Additional Manufacturer Narrative · 0

    CORRECTION: B5 - DESCRIBE EVENT OR PROBLEM. H11 - B3: THE DATE INDICATED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED. 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 AND TEST BASE PART NUMBER 195-430H/ LOT 223637. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 227687Y 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN UNKNOWN NUMBER OF FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON UNKNOWN DATES. THE SAMPLE AND SWAB TYPES WERE NOT PROVIDED. THIS MANUFACTURER'S REPORT ADDRESSES LOT ONE (1) OF TWO (2). CONFIRMATION PCR (PLATFORM - UNKNOWN) TESTING WAS PERFORMED ON UNKNOWN DATES AND GENERATED NEGATIVE RESULTS. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN UNKNOWN NUMBER OF FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON UNKNOWN DATES. THE SAMPLE AND SWAB TYPES WERE NOT PROVIDED. THIS MANUFACTURER'S REPORT ADDRESSES LOT ONE (1) OF TWO (2). CONFIRMATION PCR (PLATFORM - UNKNOWN) TESTING WAS PERFORMED ON UNKNOWN DATES AND GENERATED NEGATIVE RESULTS. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN UNKNOWN NUMBER OF FALSE POSITIVE RESULTS WITH THE BINAX NOW COVID-19 AG CARD KIT PERFORMED ON UNKNOWN DATES. THE SAMPLE AND SWAB TYPES WERE NOT PROVIDED. THIS MANUFACTURER'S REPORT ADDRESSES LOT ONE (1) OF TWO (2). CONFIRMATION PCR (PLATFORM - UNKNOWN) TESTING WAS PERFORMED ON UNKNOWN DATES AND GENERATED NEGATIVE RESULTS. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2184723 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