BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG CARD

    MDR report key: 15153517 · Received August 2, 2022

    Report

    Report Number
    1221359-2022-04219
    Event Type
    Malfunction
    Date Received
    August 2, 2022
    Date of Event
    May 12, 2022
    Report Date
    August 15, 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

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REFERENCE MFR. REPORTS: 1221359-2022-04212 THROUGH 1221359-2022-04219 AND 1221359-2022-04221 THROUGH 1221359-2022-04239.

    Additional Manufacturer Narrative · 0

    INVESTIGATION REPORT: TESTING WAS PERFORMED IN TRIPLICATE AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 187349 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 187349 AND DEVICE PART NUMBER 195-430H / LOT 181652. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE AND FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 187349 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 THE SPECIFIC PATIENT SAMPLES.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TWENTY-SEVEN (27) FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG CARD OCCURRING IN THE MONTH OF (B)(6) 2022. THIS MFR. REPORT ADDRESSES TEST EIGHT (8) OF TWENTY-SEVEN (27) AND LOT 187349 (TOTAL QUANTITY: 3). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG CARD PERFORMED ON (B)(6) 2022 ON A NASAL SAMPLE WITH THE KIT SWAB. REPEAT TESTING WAS PERFORMED AND GENERATED A NEGATIVE RESULT. PCR CONFIRMATION TESTING (PLATFORM: PERKIN-ELMER) GENERATED A POSITIVE RESULT AND WAS PERFORMED WITHIN 48 HOURS. PER THE CUSTOMER, THE CONFIRMATION TEST WAS PERFORMED WHEN EITHER SYMPTOMATIC PATIENTS RECEIVE NEGATIVE RESULTS WITH BINAXNOW COVID-19 AG CARD, OR UPON REQUEST OF THE PATIENT OR HEALTHCARE PROVIDER. THE PATIENT WAS SYMPTOMATIC AND WAS NOT KNOWN TO BE COVID-19 POSITIVE 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, ROUTINE TESTING WAS BEING PERFORMED IN K-12 SCHOOLS 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
    2334225 BINAXNOW COVID-19 AG CARD CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 187349 10811877011290

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Female