BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 18002821 · Received October 25, 2023

    Report

    Report Number
    1221359-2023-01573
    Event Type
    Malfunction
    Date Received
    October 25, 2023
    Date of Event
    October 12, 2023
    Report Date
    November 6, 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: THE CONSUMER REPORTED TWO LOT NUMBERS 205734 AND 211025 FOR TESTS PERFORMED ON (B)(6)2023. SINCE WE ARE NOT CERTAIN OF WHICH TEST PROVIDED THE CORRECT RESULT SEE BELOW FOR LOT INFORMATION. INFORMATION FOR LOT NUMBER: 205734 EXPIRATION DATE: 14JAN2024 UDI: (B)(4) INFORMATION FOR LOT NUMBER: 211025 EXPIRATION DATE: 14 APR2024 UDI:(B)(4) TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 205734 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 205734, TEST BASE PART NUMBER 195-430H/ LOT 200635. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE AND FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 205734 SHOWED THAT THE COMPLAINT RATE IS (B)(4). AND (B)(4) RESPECTIVELY. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 211025 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 211025, TEST BASE PART NUMBER 195-430H / LOT 206732. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE AND FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 211025 SHOWED THAT THE COMPLAINT RATE IS (B)(4) AND(B)(4) RESPECTIVELY. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, HOWEVER IT COULD HAVE POSSIBLY BEEN RELATED TO THE SPECIFIC PATIENT SAMPLE. H3 OTHER TEXT : SINGLE USE DEVICE: DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    D4: THE CONSUMER REPORTED TWO LOT NUMBERS 205734 AND 211025 FOR TESTS PERFORMED ON 12OCT2023. SINCE WE ARE NOT CERTAIN OF WHICH TEST PROVIDED THE CORRECT RESULT SEE BELOW FOR LOT INFORMATION. INFORMATION FOR LOT NUMBER: 205734, EXPIRATION DATE: 14JAN2024, UDI: (B)(4). INFORMATION FOR LOT NUMBER: 211025, EXPIRATION DATE: 14 APR2024, 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: DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED CONFLICTING RESULTS WITH TWO BINAXNOW COVID-19 ANTIGEN SELF TESTS PERFORMED ON (B)(6)2023. THE RESULT FROM THE FIRST TEST WAS POSITIVE. THE REPEAT TEST GENERATED A NEGATIVE RESULT. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED CONFLICTING RESULTS WITH TWO BINAXNOW COVID-19 ANTIGEN SELF TESTS PERFORMED ON (B)(6) 2023. THE RESULT FROM THE FIRST TEST WAS POSITIVE. THE REPEAT TEST GENERATED A NEGATIVE RESULT. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1433870 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown