BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    MDR report key: 15451511 · Received September 19, 2022

    Report

    Report Number
    1221359-2022-04538
    Event Type
    Malfunction
    Date Received
    September 19, 2022
    Report Date
    September 19, 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

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 182608 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 182608, TEST BASE PART NUMBER 195-430H / LOT 180010. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 182608 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS (B)(4), INC. 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. REFERENCE MFR. REPORTS: 1221359-2022-04528 THROUGH 1221359-2022-04545.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED EIGHTEEN (18) FALSE NEGATIVES WITH BINAXNOW COVID-19 SELF-TEST ASSAY PERFORMED ON DATES FROM (B)(6) 2022 ON NASAL SWAB INVOLVING VARIOUS LOTS. A CONFIRMATORY TEST (PCR) WAS PERFORMED ,AND GENERATED A POSITIVE RESULT. THE CUSTOMER WAS SYMPTOMATIC FOR TWO DAYS, THEN TESTED POSITIVE WITH PCR ON (B)(6) 2022. THIS REPORT IS ELEVEN (11) OF EIGHTEEN (18) AND ADDRESSES LOT 182608 (TOTAL QUANTITY 12). NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126963 BINAXNOW COVID-19 ANTIGEN SELF-TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC 182608 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male