BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 19258566 · Received May 7, 2024

    Report

    Report Number
    1221359-2024-00375
    Event Type
    Malfunction
    Date Received
    May 7, 2024
    Date of Event
    April 17, 2024
    Report Date
    May 7, 2024
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 223201 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 195-160 / LOT 223201, TEST BASE PART NUMBER 195-430H / LOT 220510. 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 223201 SHOWED THAT THE COMPLAINT RATE IS 0.00134%. 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, INTERPRETATION OF THE RESULT, OR THE SPECIFIC PATIENT SAMPLE.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED TWO (2) FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST FOR TWO PATIENTS PERFORMED ON (B)(6) 2024 WITH NASAL SWAB. THIS MFR. REPORT ADDRESSES PATIENT ONE (1) OF TWO (2). THE CONSUMER PREVIOUSLY TESTED POSITIVE ON (B)(6) 2024. REPEAT TESTING WAS PERFORMED COUPLE OF DAYS AFTER (B)(6) 2024 AND BEFORE (B)(6) 2024 WHICH GENERATED A NEGATIVE RESULT. THE CONSUMER REPORTED THAT THEY TESTED NEGATIVE AFTER THEY TOOK PAXLOVID. THE CONSUMER STATED THE PATIENT WAS SYMPTOMATIC (SYMPTOMS LIKE RUNNY NOSE, A BIT OF COUGH). NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670605 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 223201 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male