BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 18667357 · Received February 8, 2024

    Report

    Report Number
    1221359-2024-00157
    Event Type
    Malfunction
    Date Received
    February 8, 2024
    Date of Event
    January 4, 2024
    Report Date
    March 12, 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

    THE CUSTOMER REPORTED TWO AFFECTED LOT NUMBERS 225711 AND 225201, SINCE WE ARE NOT CERTAIN OF WHICH TEST WAS PERFORMED ON WHICH DATE SEE BELOW FOR LOT INFORMATION. INFORMATION FOR LOT NUMBER: 225711. EXPIRATION DATE: 23AUG2024. UDI: (B)(4). INFORMATION FOR LOT NUMBER: 225201. EXPIRATION DATE: 29JUL2024. UDI: (B)(4). THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION OR UPON RECEIPT OF NEW INFORMATION. H3 OTHER TEXT : SINGLE USE DEVICE: DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED TWO AFFECTED LOT NUMBERS 225711 AND 225201, SINCE WE ARE NOT CERTAIN OF WHICH TEST WAS PERFORMED ON WHICH DATE SEE BELOW FOR LOT INFORMATION. INFORMATION FOR LOT NUMBER: 225711, EXPIRATION DATE: 23AUG2024, UDI: (B)(4). INFORMATION FOR LOT NUMBER: 225201, EXPIRATION DATE: 29JUL2024, UDI: (B)(4). TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 225711 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 225711, TEST BASE PART NUMBER 195-430WJR / LOT 223210. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 225201 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 225201, TEST BASE PART NUMBER 195-430H / LOT 220864. 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 225711 SHOWED THAT THE COMPLAINT RATE IS (B)(4). A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 225201 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 THE SPECIFIC PATIENT SAMPLE.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON DIFFERENT DATES. THIS MFR. REPORT IS THREE (3) OF THREE (3). THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2024. ADDITIONAL TESTING WAS PERFORMED TWICE ON (B)(6) 2024: ONCE AT AN URGENT CARE WITH AN UNKNOWN TEST AND THE SECOND WITH IHEALTH RAPID TEST. BOTH METHODS GENERATED A POSITIVE RESULT. THE CONSUMER STATED THE PATIENT WAS SYMPTOMATIC AND DID NOT GET PROPER DIAGNOSIS DUE TO FALSE RESULTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED. THE CONSUMER REPORTED THE FALSE NEGATIVE RESULTS VIA MEDWATCH (MW5150033 AND MW5150034).

    Description of Event or Problem · 0

    THE CONSUMER REPORTED FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON DIFFERENT DATES. THIS MFR. REPORT IS THREE (3) OF THREE (3). THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2024 ADDITIONAL TESTING WAS PERFORMED TWICE ON (B)(6) 2024: ONCE AT AN URGENT CARE WITH AN UNKNOWN TEST AND THE SECOND WITH IHEALTH RAPID TEST. BOTH METHODS GENERATED A POSITIVE RESULT. THE CONSUMER STATED THE PATIENT WAS SYMPTOMATIC AND DID NOT GET PROPER DIAGNOSIS DUE TO FALSE RESULTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED. THE CONSUMER REPORTED THE FALSE NEGATIVE RESULTS VIA MEDWATCH (MW5150033 AND MW5150034).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787766 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 NA Unknown