BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 17993291 · Received October 23, 2023

    Report

    Report Number
    1221359-2023-01570
    Event Type
    Malfunction
    Date Received
    October 23, 2023
    Date of Event
    October 1, 2023
    Report Date
    October 23, 2023
    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

    D4-UDI:(B)(4). TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 225141 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: 225141, TEST BASE PART NUMBER 195-430WJR/ LOT: 222477. 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 225141 SHOWED THAT THE COMPLAINT RATE IS 0.000325%. ABBOTT DIAGNOSTICS SCARBOROUGH, 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. H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2023 ON A NASAL KITTED SWAB. REPEAT TESTING WAS NOT PERFORMED. INITIAL TESTING WAS PERFORMED ON (B)(6) 2023 VIA AN UNKNOWN BRAND OF RAPID ANTIGEN TEST WHICH GENERATED A NEGATIVE RESULT. ADDITIONAL TESTING WAS PERFORMED ON (B)(6) 2023 VIA AN IHEALTH RAPID ANTIGEN TEST WHICH GENERATED A POSITIVE RESULT. THE CONSUMER STATED THEY EXPERIENCED SYMPTOMS SUCH AS CHILLS AND HIGH FEVER THAT STARTED (B)(6) 2023 AND LASTED FOR TWO (2) DAYS. THE CONSUMER CONFIRMED THERE WAS NO HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CONSUMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788458 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 225141 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female