BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW¿ COVID-19 ANTIGEN SELF TEST

    MDR report key: 11910770 · Received May 31, 2021

    Report

    Report Number
    1221359-2021-01621
    Event Type
    Malfunction
    Date Received
    May 31, 2021
    Date of Event
    April 30, 2021
    Report Date
    December 16, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCABOROUGH
    Product Code
    QKP
    UDI-DI
    00811877011408
    PMA / PMN Number
    EUA210264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE CORRECTED DATA AND ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: INVESTIGATION: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 152922 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 BASE PART NUMBER KIT PART NUMBER 195-160 & 195-260 / LOTS 152922 & 152992A. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 152922 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 POSSIBLY BE RELATED TO THE SPECIFIC PATIENT/VALIDATION SAMPLES.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 152922 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 BASE PART NUMBER KIT PART NUMBER 195-160 & 195-260 / LOTS 152922 & 152992A. 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 152922 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 POSSIBLY BE RELATED TO THE SPECIFIC PATIENT/VALIDATION SAMPLES.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NEGATIVE WITH THE BINAXNOW¿ COVID-19 ANTIGEN SELF TEST OTC PERFORMED ON 22APR2021. THE FIRST TEST WAS PERFORMED ON 22APR2021 WITH POSITIVE RESULTS. REPEAT TESTING WAS PERFORMED ON 30APR2021 WITH NEGATIVE RESULTS. CONFIRMATION TESTING WAS PERFORMED THE FOLLOWING DAY WHICH GENERATED A POSITIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED. THE CUSTOMER WAS SYMPTOMATIC. THE CUSTOMER CONFIRMED THERE WAS NO HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN TREATMENT.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE NEGATIVE WITH THE BINAXNOW¿ COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2021. CONSUMER PERFORMED INITIAL TEST ON (B)(6) 2021 RESULTED A POSITIVE RESULT AND CONFIRMED THEY HAD SYMPTOMS BEFORE 24 HOURS OF INITIAL TESTING. CONFIRMATION TESTING WAS PERFORMED THE FOLLOWING DAY AT CVS, WHICH GENERATED A POSITIVE RESULT. CONSUMER HAD NO SYMPTOMS FOR 2 DAYS WHEN REPEAT TESTING WAS PERFORMED ON (B)(6) 2021 WITH NEGATIVE RESULT. THE CONSUMER CONFIRMED THERE WAS NO HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN TREATMENT.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED CONFLICTING RESULT WITH THE BINAXNOW¿ COVID-19 ANTIGEN SELF TEST OTC PERFORMED ON (B)(6) 2021. THE FIRST TEST WAS PERFORMED ON (B)(6) 2021 WITH POSITIVE RESULTS. REPEAT TESTING WAS PERFORMED ON (B)(6) 2021 WITH NEGATIVE RESULTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED. THE CUSTOMER WAS ASYMPTOMATIC. THE CUSTOMER CONFIRMED THERE WAS NO HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806637 BINAXNOW¿ COVID-19 ANTIGEN SELF TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ABBOTT DIAGNOSTICS SCABOROUGH 152922 00811877011408
    806638 BINAXNOW¿ COVID-19 ANTIGEN SELF TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ABBOTT DIAGNOSTICS SCABOROUGH 152922 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Male