BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG CARD

    MDR report key: 14274533 · Received May 4, 2022

    Report

    Report Number
    1221359-2022-02283
    Event Type
    Malfunction
    Date Received
    May 4, 2022
    Date of Event
    March 8, 2022
    Report Date
    June 13, 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. RELATED MFR REPORT NUMBERS: 1221359-2022-02281 THROUGH 1221359-2022-02289.

    Additional Manufacturer Narrative · 0

    INVESTIGATION REPORT: TESTING WAS PERFORMED IN TRIPLICATE AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 170179 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 170179 AND DEVICE PART NUMBER 195-430H / LOT 168292. 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 170179 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED NINE (9) FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG CARD ON MULTIPLE DATES IN (B)(6) 2022 ON KITTED NASAL SWABS. THIS REPORT IS FOR PATIENT THREE (3) OF NINE (9) AND LOT 170179 (TOTAL QUANTITY 1). THE PATIENT WAS TESTED WITH THE BINAXNOW COVID-19 AG CARD ON (B)(6) 2022 WHICH GENERATED A POSITIVE RESULT. CONFIRMATION PCR TESTING WAS PERFORMED THE SAME DAY (PLATFORM:(B)(4)) ON A NASAL WHICH GENERATED A NEGATIVE RESULT. THE PATIENT WAS ASYMPTOMATIC AT THE TIME OF TESTING. NO SERIOUS INJURY, MEDICAL INTERVENTION OR TREATMENT DECISIONS OCCURRED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1318037 BINAXNOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 170179 10811877011290

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Female