BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 16530843 · Received March 13, 2023

    Report

    Report Number
    1221359-2023-00487
    Event Type
    Malfunction
    Date Received
    March 13, 2023
    Date of Event
    March 9, 2023
    Report Date
    May 15, 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
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. SINGLE USE; DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 221443 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 221443 AND TEST BASE PART NUMBER 195-430H/LOT 209994. 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 221443 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. HOWEVER, A POSSIBLE ASSIGNABLE ROOT CAUSE IS SAMPLE INTERFERENCE OR CROSS CONTAMINATION. H3 OTHER TEXT: SINGLE USE; DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF-TEST PERFORMED ON (B)(6) 2023 ON A NASAL SWAB. AS PER CONSUMER INITIAL TESTING WAS PERFORMED BY A DOCTOR ON A UNKNOWN PLATFORM AND GENERATED A POSITIVE RESULT. THE CONSUMER STATED SHE WAS SYMPTOMATIC. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF-TEST PERFORMED ON (B)(6) 2023 ON A NASAL SWAB. AS PER CONSUMER INITIAL TESTING WAS PERFORMED BY A DOCTOR ON A UNKNOW PLATFORM AND GENERATED A POSITIVE RESULT. THE CONSUMER STATED SHE WAS SYMPTOMATIC. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2007759 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 221443 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female