BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG CARD

    MDR report key: 15509817 · Received September 30, 2022

    Report

    Report Number
    1221359-2022-04768
    Event Type
    Malfunction
    Date Received
    September 30, 2022
    Date of Event
    June 27, 2022
    Report Date
    September 29, 2022
    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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 185812 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 195-000 / LOT 185812 AND DEVICE PART NUMBER 195-430H / LOT 182143. 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 185812 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 POSSIBLY BE RELATED TO THE SPECIFIC PATIENT SAMPLES. REFERENCE RELATED MFR. REPORT NUMBERS: 1221359-2022-04759.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TEN (10) FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG CARD OCCURRING IN THE MONTH OF (B)(6) 2022 PERFORMED ON MULTIPLE PATIENTS. THIS MFR. REPORT ADDRESSES RESULT TEN (10) OF TEN (10). THE PATIENT TESTED POSITIVE WITH THE BINAXNOW COVID-19 AG CARD ON A NASAL SWAB SAMPLE ON (B)(6) 2022. CONFIRMATION TESTING WAS PERFORMED WITHIN 48 HOURS MOLECULAR TESTING (PCR OR LAMP) USING A SAMPLE OBTAINED AT THE SAME SITE ON THE SAME DAY AND GENERATED POSITIVE RESULTS. THE PATIENT WAS REPORTED TO HAVE BEEN SYMPTOMATIC AT THE TIME OF TESTING. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT. PER THE CUSTOMER NO ADDITIONAL INFORMATION WILL BE PROVIDED ON THE FALSE NEGATIVE RESULTS OR INDIVIDUALS TESTED. PER THE CUSTOMER, ROUTINE TESTING WAS BEING PERFORMED AT COMMUNITY ORGANIZATIONS (NON K-12 SCHOOLS, NON LONG TERM CARE FACILITIES) AND THE AG CARDS HAVE BEEN FUNCTIONING AS EXPECTED. THE CUSTOMER DID NOT ALLEGE A MALFUNCTION OF THE DEVICE AND CONFIRMED THIS IS ROUTINE REPORTING PER THE BINAXNOW COVID-19 AG CARD INSTRUCTIONS FOR USE (IFU).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1634098 BINAXNOW COVID-19 AG CARD CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 185812 10811877011290

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male