BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 16766177 · Received April 18, 2023

    Report

    Report Number
    1221359-2023-00645
    Event Type
    Malfunction
    Date Received
    April 18, 2023
    Date of Event
    April 4, 2023
    Report Date
    May 25, 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

    THE INVESTIGATION IS ONGOING. A SUPPLEMENT REPORT WILL BE SENT UPON INVESTIGATION COMPLETION. SINGLE USE DEVICE, DISCARDED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 214045 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 195-160 / LOT 214045 AND DEVICE PART NUMBER 195-430WJR / LOT 212379. 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 214045 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. H3 OTHER TEXT : SINGLE USE DEVICE, DISCARDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED TWO (2) UNCONFIRMED FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG SELF-TEST ON (B)(6) 2023. THIS REPORT IS FOR RESULT ONE (1) OF TWO (2). THE CONSUMER INDICATED THAT THEY PERFORMED A NON-ABBOTT SELF-TEST (BRAND NAME UNKNOWN) WHICH GENERATED A NEGATIVE RESULT ON AN UNKNOWN DATE. NO ADDITIONAL INFORMATION INCLUDING PATIENT TREATMENT OR OUTCOME WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED TWO (2) UNCONFIRMED FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG SELF-TEST ON (B)(6) 2023. THIS REPORT IS FOR RESULT ONE (1) OF TWO (2). THE CONSUMER INDICATED THAT THEY PERFORMED A NON-ABBOTT SELF-TEST (BRAND NAME UNKNOWN) WHICH GENERATED A NEGATIVE RESULT ON AN UNKNOWN DATE. NO ADDITIONAL INFORMATION INCLUDING PATIENT TREATMENT OR OUTCOME WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1210977 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 214045 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown