BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    MDR report key: 15179662 · Received August 5, 2022

    Report

    Report Number
    1221359-2022-03444
    Event Type
    Malfunction
    Date Received
    August 5, 2022
    Date of Event
    June 23, 2022
    Report Date
    October 24, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    00811877011408
    PMA / PMN Number
    EUA210264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    INVESTIGATION REPORT: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 192468 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE INCOMING RECEIPT INSPECTION RECORDS AND THE CERTIFICATE OF COMPLIANCE WAS REVIEWED FOR COMPONENT PART NUMBER PK002545 / LOT P0667. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. THE INCOMING RECEIPT INSPECTION RECORDS AND THE CERTIFICATE OF COMPLIANCE WAS REVIEWED FOR COMPONENT PART NUMBER PK002545 / LOT P0665 AND THERE WERE NO NOTES REGARDING SWAB DEFECTS FOUND. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. THE INCOMING RECEIPT INSPECTION RECORDS AND THE CERTIFICATE OF COMPLIANCE WAS REVIEWED FOR COMPONENT PART NUMBER PK002545 / LOT P0625 AND THERE WERE NO NOTES REGARDING SWAB DEFECTS FOUND. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS BROKEN / DAMAGED / DEFECTIVE SWAB RELATED TO KIT LOT 192468 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 ISSUES INCLUDING THE SELF-TEST USER PERFORMANCE.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED VIA MEDWATCH REPORT, MW5110699, THAT THE TIP OF THE NASAL SWAB FROM THE BINAXNOW COVID-19 ANTIGEN SELF-TEST CAME OFF OF THE STICK DEEP IN THEIR RIGHT NOSTRIL. THE CONSUMER WENT TO THE EMERGENCY ROOM (ER) WHERE A VARIETY OF DIFFERENT CURRETTES WERE USED TO REMOVE THE SWAB TIP. NO MEDICATION WAS PERSCRIBED; CONSUMER ONLY REPORTED DISCOMFORT. THE CONSUMER CONFIRMED THERE WAS NO HARM, DELAY OR IMPACT IN TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2519008 BINAXNOW COVID-19 ANTIGEN SELF-TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 192468 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male