BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST

    MDR report key: 13083156 · Received December 23, 2021

    Report

    Report Number
    1221359-2021-03760
    Event Type
    Malfunction
    Date Received
    December 23, 2021
    Report Date
    May 24, 2022
    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
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 160870 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 160870 AND TEST BASE PART NUMBER 195-430WL/LOT 156077. 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 160870 SHOWED THAT THE COMPLAINT RATE IS (B)(4). IN CONCLUSION, 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. REFERENCE MFR NUMBER - 1221359-2022-00508.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE ADDITIONAL INFORMATION AND CORRECTION. PLEASE SEE UPDATES: G3, G6 AND H2. CORRECTION : THIS REPORT IS BEING CORRECTED FROM PREVIOUS REPORT OF AN ALERGIC REACTION TO A FALSE POSITIVE. NO ALERGIC REACTION OCCURED. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER 29 DEC 2021 STATES IT WAS TWO FALSE POSITIVES , CUSTOMER WILL NOT BE PROVIDING PATIENT INFORMATION.

    Description of Event or Problem · 0

    THE USER REPORTED AN ALLERGIC REACTION WITH THE BINAXNOW¿ COVID-19 ANTIGEN SELF TEST PERFORMED ON A DIRECT TESTED NASAL KITTED SWAB AND GENERATED A POSITIVE RESULTS. THE USER REPORTED REPEAT TESTING WAS PERFORMED AND AGAIN RECEIVED A POSITIVE RESULTS. THE USER REPORTED THAT ON THE SAME DAY WENT TO THE EMERGENCY ROOM AND PCR CONFIRMATION TESTING WAS PERFORMED AND GENERATED A NEGATIVE. NO TREATMENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1969909 BINAXNOW COVID-19 AG SELF TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 160870 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown