BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW¿ COVID-19 ANTIGEN SELF TEST OTC

    MDR report key: 11908195 · Received May 31, 2021

    Report

    Report Number
    1221359-2021-01617
    Event Type
    Malfunction
    Date Received
    May 31, 2021
    Report Date
    November 30, 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

    THE CUSTOMER REPORTED CONFLICTING RESULTS WITH THE BINAXNOW¿ COVID-19 ANTIGEN SELF TEST OTC 2 TEST PACK. THE CUSTOMER REPORTED THAT THE INITIAL TEST RESTULTS WERE NEGATIVE UPON RETESTING SHE RECEIVED POSITIVE RESULTS. PCR CONFIRMATION TESTING WAS PERFORMED WITH UNKNOWN RESULTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 153476 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 153476 AND DEVICE PART NUMBER 195-430H / LOT 148405. 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 153476 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE

    Additional Manufacturer Narrative · 0

    THE SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT THE PREVIOUSLY REPORTED EVENT AND PROVIDE ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION NOT YET COMPLETE. UPON COMPLETION, THE INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW¿ COVID-19 ANTIGEN SELF TEST OTC 2 TEST PACK. REPEAT TESTING WAS PERFORMED WITH NEGATIVE RESULTS. PCR CONFIRMATION TESTING WAS PERFORMED WITH UNKNOWN RESULTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806029 BINAXNOW¿ COVID-19 ANTIGEN SELF TEST OTC LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCABOROUGH 153476 00811877011408
    806038 BINAXNOW¿ COVID-19 ANTIGEN SELF TEST OTC LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCABOROUGH 153476 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Male