BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BINAXNOW COVID-19 AG CARD

    MDR report key: 11852368 · Received May 19, 2021

    Report

    Report Number
    1221359-2021-01509
    Event Type
    Injury
    Date Received
    May 19, 2021
    Date of Event
    April 22, 2021
    Report Date
    December 29, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    PMA / PMN Number
    EUA202537
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M144024 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 NUMBER 190-000 / LOT: M144024, TEST BASE PART NUMBER 190-430 / LOT: M144024. 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 M144024 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE HOWEVER A POSSIBLE ASSIGNABLE ROOT CAUSE IS SAMPLE INTERFERENCE OR CROSS CONTAMINATION.

    Additional Manufacturer Narrative · 0

    B5: PER THE CUSTOMER PATIENT IS DOING WELL. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: MDR 1221359-2021-01509 FOLLOW UP (2) TWO WAS SENT IN MISTAKE. PLEASE RETRACT FOLLOW UP TWO (2).

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE PACKAGE INSERT IN195000 V2.0: 21. THE EXTRACTION REAGENT PACKAGED IN THIS KIT CONTAINS SALINE, DETERGENTS AND PRESERVATIVES THAT WILL INACTIVATE CELLS AND VIRUS PARTICLES. SAMPLES ELUTED IN THIS SOLUTION ARE NOT SUITABLE FOR CULTURE.

    Additional Manufacturer Narrative · 1

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE USING THE BINAXNOW COVID-19 AG CARD TO PERFORM A SELF-TEST ON (B)(6) 2021, SHE ACCIDENTALLY PLACED REAGENT SOLUTION ON THE SWAB AND THEN INSERTED THE SWAB UP HER NOSE. THE CUSTOMER CLARIFIED THAT SHE IS AWARE ON THE CORRECT TESTING PROCEDURE, BUT WAS BECAME DISTRACTED WHILE PERFORMING THE TEST. PER THE CUSTOMER SHE COULD TASTE THE REAGENT BUT NO OTHER SIDE EFFECTS OCCURRED AND CONFIRMED NO PATIENT HARM OR TREATMENT DELAY/IMPACT OCCURRED DUE TO THE INADVERTENT ISSUE. THE PATIENT WAS ADVISED TO SEE A PHYSICIAN IN THE EVENT SHE STARTS TO FEEL UNWELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747092 BINAXNOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M144024

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other