BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG CARD

    MDR report key: 15052626 · Received July 19, 2022

    Report

    Report Number
    1221359-2022-02469
    Event Type
    Malfunction
    Date Received
    July 19, 2022
    Date of Event
    December 30, 2021
    Report Date
    July 28, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS . A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REFERENCE MFR. REPORTS: 1221359-2022-02455 THROUGH 1221359-2022-02471. PATIENT IDENTIFIER: (B)(6).

    Additional Manufacturer Narrative · 0

    CORRECTED DATA : D4 (EXPIRATION DATE). TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 172101 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 195-000/ LOT 172101 ,TEST BASE PART NUMBER 195-430WL / LOT 169537. 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 172101 (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. H10: REFERENCE MFR. REPORTS: 1221359-2022-02455 THROUGH 1221359-2022-02471.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED SEVENTEEN (17) FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG CARD ON MULTIPLE DATES IN DECEMBER, 2021 ON KITTED NASAL SWABS. THIS MFR. REPORT IS FOR TEST FIFTEEN (15) OF SEVENTEEN (17) TESTS AND LOT 172101 (TOTAL QUANTITY 1). THE PATIENT WAS TESTED WITH THE BINAXNOW COVID-19 AG CARD ON (B)(6) 2021 WHICH GENERATED A POSITIVE RESULT. CONFIRMATION PCR TESTING WAS PERFORMED THE SAME DAY (PLATFORM: PERKINELMER) ON A NASAL WHICH GENERATED A NEGATIVE RESULT. THE PATIENT WAS SYMPTOMATIC . NO SERIOUS INJURY, MEDICAL INTERVENTION OR TREATMENT DECISIONS OCCURRED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262418 BINAXNOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC 172101 10811877011290

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female