BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF TEST

    MDR report key: 12849958 · Received November 21, 2021

    Report

    Report Number
    1221359-2021-03565
    Event Type
    Malfunction
    Date Received
    November 21, 2021
    Date of Event
    October 14, 2021
    Report Date
    April 25, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCABOROUGH
    Product Code
    QKP
    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

    INVESTIGATION REPORT: TESTING WAS PERFORMED IN TRIPLICATE AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 160130 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 195-160/195-260 / LOT 160130 AND DEVICE PART NUMBER 195-430WL / LOT 153061. 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 160130 SHOWED THAT THE COMPLAINT RATE IS (B)(4)%. ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE USER REPORTED CONFLICTING RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON (B)(6) 2021 ON A DIRECT TESTED NASAL KITTED SWAB. THE USER STATES THAT THE INITIAL COVID TEST (UNKNOWN TEST TYPE) PERFORMED ON (B)(6) 2021 GENERATED POSITIVE RESULTS. REPEAT TESTING WITH BINAXNOW COVID-19 AG SELF TEST PERFORMED ON (B)(6) 2021 GENERATED NEGATIVE RESULTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1747519 BINAXNOW COVID-19 ANTIGEN SELF TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCABOROUGH 160130

    Patients

    Seq Age Sex Outcome Treatment
    1 Female