BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    MDR report key: 15465536 · Received September 22, 2022

    Report

    Report Number
    1221359-2022-04548
    Event Type
    Malfunction
    Date Received
    September 22, 2022
    Date of Event
    January 1, 2022
    Report Date
    October 31, 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

    INVESTIGATION REPORT: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 182285 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 KIT PART NUMBER 182285 / LOT 182285 AND DEVICE PART NUMBER 195-430H / LOT 180464. 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 182285 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, INTERPRETATION OF THE RESULT, OR THE SPECIFIC PATIENT SAMPLE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: EVENT DATE IS AN APPROXIMATION. THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REFERENCE RELATED MFR. REPORT NUMBERS: 1221359-2022-04771 AND 1221359-2022-04772.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THREE (3) FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON VARIOUS DATES OVER SEVERAL WEEKS USING SAME LOT. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF THREE (3). THE CONSUMER TESTED POSITIVE WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON A NASAL SWAB SAMPLE. CONFIRMATION TESTING WAS PERFORMED VIA SEVERAL UNKNOWN RAPID TESTS AND ONE PCR TEST. ALTHOUGH REQUESTED, THE EXACT BRAND, QUANTITY OF TESTS, AND DATES OF TESTING WERE NOT PROVIDED. ALL CONFIRMATORY TESTS GENERATED POSITIVE RESULTS. PATIENT WAS SYMPTOMATIC- HAD COLD-LIKE SYMPTOMS ON EACH OCCASION. NO ADDITIONAL INFORMATION INCLUDING PATIENT HEALTH STATUS OR OUTCOME WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2645267 BINAXNOW COVID-19 ANTIGEN SELF-TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM, PRODUCT QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 182285 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Male