BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BINAX NOW COVID-19 AG CARD

    MDR report key: 12322096 · Received August 13, 2021

    Report

    Report Number
    1221359-2021-02267
    Event Type
    Injury
    Date Received
    August 13, 2021
    Report Date
    May 12, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    PMA / PMN Number
    EUA210264
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1032793 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 1032793 AND TEST BASE PART NUMBER 190-430 / LOT 1032793. 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 1032793 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 PATIENT SAMPLE INTERFERENCE.

    Additional Manufacturer Narrative · 0

    A PRODUCT DEFICIENCY WAS NOT REPORTED OR IDENTIFIED. BASED ON THE ABOVE SUMMARY, THE INVESTIGATION IS DEEMED COMPLETE. THE PRODUCT WILL CONTINUE TO BE MONITORED AND TRACKED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT ON (B)(6) 2021, AFTER TAKING A NASAL SAMPLE FROM THEIR SON TO ADMINISTER THE BINAXNOW¿ COVID-19 ANTIGEN SELF TEST BLOOD APPEARED. THE CONSUMER REPORTED THAT THE BLEEDING WAS MOST LIKELY CAUSED BY THE SWAB BEING INSERTED A BIT TOO FAR. THE CONSUMER REPORTED THAT THE SWAB WAS RED. THE CONSUMER THEN INQUIRED IF THE CONTROL LINE WAS MEANT TO STAY BLUE BECAUSE THE USER'S HAD YET TO CHANGE. TECHNICAL SERVICES INFORMED THE USER THAT BEFORE TESTING SHE WOULD NEED TO MAKE SURE A BLUE CONTROL LINE IS ALWAYS PRESENT AND THEN AFTER TESTING THE BLUE CONTROL LINE IS MEANT TO CHANGE TO PINK AFTER THE 15 MINUTES. ALSO, THAT THE RESULTS SHOULD ONLY BE READ BETWEEN THE INSTRUCTED 15-30 MINUTES; NOT BEFORE OR AFTER. IN THIS CASE, TECHNICAL SERVICE SUGGESTED THAT THE USER NOT TO TAKE THE RESULTS INTO CONSIDERATION AND A SECOND KIT WOULD NEED TO BE PURCHASED SO HER SON COULD LATER ON HAVE THE TWO TEST CARDS REQUIRED. TECHNICAL SERVICES INFORMED THE CONSUMER THAT ONCE HER SON WAS TREATED FOR HIS NOSE BLEED AND HE FELT BETTER HE COULD THEN TRY TO RETEST AGAIN. THE CUSTOMER AGREED TO TAKE HER SON TO HIS DOCTOR TO TREAT HIS NOSE BLEED. NO ADDITIONAL INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1214824 BINAX NOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 153354

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Male Other