BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 18777240 · Received February 26, 2024

    Report

    Report Number
    1221359-2024-00222
    Event Type
    Malfunction
    Date Received
    February 26, 2024
    Date of Event
    February 7, 2024
    Report Date
    March 19, 2024
    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

    FDA UDI - (B)(6) TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 226419 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 226419 AND TEST BASE PART NUMBER 195-430WJR/ LOT 223602. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 226419 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 HAVE POSSIBLY BEEN 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.

    Additional Manufacturer Narrative · 0

    FDA UDI - (B)(4). THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED 5 FALSE NEGATIVE RESULTS WITH A BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON VARIOUS DATES ON A NASAL SAMPLE. THIS MANUFACTURER'S REPORT ADDRESSES TEST FOUR (4) OF FIVE (5). REPEAT TESTING WAS PERFORMED BETWEEN (B)(6)2024 AND(B)(6)2024 AND GENERATED NEGATIVE RESULTS. CONFIRMATION TESTING WAS NOT PERFORMED. CONSUMER PERFORMED AN IHEALTH ANTIGEN SELF-TEST ON (B)(6)2024 AND GENERATED A POSITIVE RESULT. THE CONSUMER HAD SYMPTOMS OF COUGH, COLDS, SORE THROAT, FEVER, RUNNY NOSE. THE CONSUMER CONFIRMED THERE WAS NO HARM DUE TO THE TEST RESULT. ADDITIONALLY, THE CONSUMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THEIR TREATMENT.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED 5 FALSE NEGATIVE RESULTS WITH A BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON VARIOUS DATES ON A NASAL SAMPLE. THIS MANUFACTURER'S REPORT ADDRESSES TEST FOUR (4) OF FIVE (5). REPEAT TESTING WAS PERFORMED BETWEEN (B)(6) 2024 AND GENERATED NEGATIVE RESULTS. CONFIRMATION TESTING WAS NOT PERFORMED. CONSUMER PERFORMED AN IHEALTH ANTIGEN SELF-TEST ON 05FEB2024 AND GENERATED A POSITIVE RESULT. THE CONSUMER HAD SYMPTOMS OF COUGH, COLDS, SORE THROAT, FEVER, RUNNY NOSE. THE CONSUMER CONFIRMED THERE WAS NO HARM DUE TO THE TEST RESULT. ADDITIONALLY, THE CONSUMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THEIR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298511 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 226419 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female