BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 15870826 · Received November 28, 2022

    Report

    Report Number
    1221359-2022-10188
    Event Type
    Malfunction
    Date Received
    November 28, 2022
    Date of Event
    November 9, 2022
    Report Date
    January 31, 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

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 211966 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 211966, TEST BASE PART NUMBER 195-430WJR / LOT 209391. 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 211966 SHOWED THAT THE COMPLAINT RATE IS (B)(4). 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 : DEVICE DISCARDED, SINGLE USE.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. DEVICE DISCARDED, SINGLE USE.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED FIVE (5) FALSE NEGATIVE RESULTS WITH BINAXNOW COVID-19 AG SELF-TEST ON 09NOV2022. THE CONSUMER STATED THAT SHE AND HER DAUGHTER WERE EXPOSED TO COVID, SO THEY ISOLATED THEMSELVES FOR 5 DAYS, AND TOOK THE BINAXNOW TEST FOR 5 DAYS CONTINUOUSLY AND GOT NEGATIVE RESULTS EACH TIME. ON 09NOV2022, SHE TESTED AGAIN WITH ANTIGEN TEST AND GOT NEGATIVE AND ON SAME DAY HER DAUGHTER TESTED POSITIVE FOR COVID WITH PCR TEST.THIS MFR. REPORT ADDRESSES TEST ONE (1) OF FIVE (5) TESTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED FIVE (5) FALSE NEGATIVE RESULTS WITH BINAXNOW COVID-19 AG SELF-TEST ON (B)(6) 2022. THE CONSUMER STATED THAT SHE AND HER DAUGHTER WERE EXPOSED TO COVID, SO THEY ISOLATED THEMSELVES FOR 5 DAYS, AND TOOK THE BINAXNOW TEST FOR 5 DAYS CONTINUOUSLY AND GOT NEGATIVE RESULTS EACH TIME. ON (B)(6) 2022, SHE TESTED AGAIN WITH ANTIGEN TEST AND GOT NEGATIVE AND ON SAME DAY HER DAUGHTER TESTED POSITIVE FOR COVID WITH PCR TEST. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF FIVE (5) TESTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2770838 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 211966 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Female