BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 19905291 · Received August 5, 2024

    Report

    Report Number
    1221359-2024-00527
    Event Type
    Malfunction
    Date Received
    August 5, 2024
    Date of Event
    July 29, 2024
    Report Date
    September 10, 2024
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    PMA / PMN Number
    EUA210264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONSUMER REPORTED THREE LOT NUMBERS 225415, 225969 AND 224701 FOR TESTS PERFORMED ON (B)(6) 2024: LOT NUMBER 225415 GENERATED A POSITIVE RESULT, AND LOT NUMBER 225969 AND 224701 GENERATED A NEGATIVE RESULT. SINCE WE ARE NOT CERTAIN OF WHICH TEST PROVIDED THE CORRECT RESULT SEE BELOW FOR LOT INFORMATION. INFORMATION FOR LOT NO. 225415. EXPIRATION DATE: 21AUG2024. UDI: (B)(4). INFORMATION FOR LOT NO. 225969. EXPIRATION DATE: 02SEP2024. UDI: (B)(4). INFORMATION FOR LOT NO. 224701. EXPIRATION DATE: 23AUG2024. UDI: (B)(4). TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 225415 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 225415, TEST BASE PART NUMBER 195-430H / LOT 220852. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 225969 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 225969, TEST BASE PART NUMBER 195-430WL / LOT 223497. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 224701 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 224701, TEST BASE PART NUMBER 195-430H / LOT 221858. 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 225415 SHOWED THAT THE COMPLAINT RATE IS (B)(4) RESPECTIVELY. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE AND FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 225969 SHOWED THAT THE COMPLAINT RATE IS (B)(4) RESPECTIVELY. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE AND FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 224701 SHOWED THAT THE COMPLAINT RATE IS (B)(4) RESPECTIVELY. 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.

    Additional Manufacturer Narrative · 0

    D4: D4: THE CONSUMER REPORTED THREE LOT NUMBERS 225415, 225969 AND 224701 FOR TESTS PERFORMED ON 29JUL2024: LOT NUMBER 225415 GENERATED A POSITIVE RESULT, AND LOT NUMBER 225969 AND 224701 GENERATED A NEGATIVE RESULT. SINCE WE ARE NOT CERTAIN OF WHICH TEST PROVIDED THE CORRECT RESULT SEE BELOW FOR LOT INFORMATION. INFORMATION FOR LOT NO. 225415. EXPIRATION DATE: 21AUG2024. UDI: (B)(4). INFORMATION FOR LOT NO. 225969. EXPIRATION DATE: 02SEP2024. UDI: (B)(4). INFORMATION FOR LOT NO. 224701. EXPIRATION DATE: 23AUG2024. UDI:(B)(4). THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION OR UPON RECEIPT OF NEW INFORMATION.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED CONFLICTING RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2024 USING TESTS FROM THE DIFFERENT LOT. THE CONSUMER STATED THE FIRST TEST GENERATED A POSITIVE RESULT AND THE SECOND TEST GENERATED A NEGATIVE RESULT. REPEAT TESTING WAS PERFORMED ON (B)(6) 2024 WHICH GENERATED A NEGATIVE RESULT. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED CONFLICTING RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2024 USING TESTS FROM THE DIFFERENT LOT. THE CONSUMER STATED THE FIRST TEST GENERATED A POSITIVE RESULT AND THE SECOND TEST GENERATED A NEGATIVE RESULT. REPEAT TESTING WAS PERFORMED ON (B)(6) 2024 WHICH GENERATED A NEGATIVE RESULT. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2293892 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown