BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAX NOW COVID-19 HOME TEST

    MDR report key: 12282146 · Received August 5, 2021

    Report

    Report Number
    1221359-2021-02218
    Event Type
    Malfunction
    Date Received
    August 5, 2021
    Date of Event
    July 14, 2021
    Report Date
    November 29, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    00811877011408
    PMA / PMN Number
    EUA210264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10: TESTING WAS PERFORMED ON RETAIN KIT LOT 153476 WITH THE ABBOTT DIAGNOSTICS SCARBOROUGH'S LIMIT OF DETECTION (LOD) POSITIVE QUALITY CONTROL X3 DEVICES AND NEGATIVE (BLANK) SWABS X3 DEVICES. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING AND QUALITY CONTROL RELEASE TESTING WERE REVIEWED FOR KIT PART NUMBER 195-160 / LOT 153476 AND DEVICE PART NUMBER 195-430H / LOT 148405 AND THEY MET RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 153476 SHOWED THAT THE COMPLAINT RATE IS (B)(4). A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 153476 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 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.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED CONFLICTING RESULT WITH THE BINAX NOW COVID-19 ANTIGEN SELF TEST. THE CUSTOMER STATED THAT HERE IS A DARK PINK LINE IN THE CONTROL AND WHEN HE PRESSED THE TEST CARD THERE IS A PINK FAINT LINE IN THE SAMPLE. THE CUSTOMER CONFIRMED THAT HE NO LONGER SEE THE PINK FAINT LINE IN THE SAMPLE AFTER HE NO LONGER PRESSED THE TEST CARD. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1181778 BINAX NOW COVID-19 HOME TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 153476 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown