BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF TEST

    MDR report key: 13416997 · Received February 1, 2022

    Report

    Report Number
    1221359-2022-00680
    Event Type
    Malfunction
    Date Received
    February 1, 2022
    Date of Event
    January 3, 2022
    Report Date
    April 19, 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

    THIS INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE PROVIDED. RELATED REPORTS: 1221359-2022-00681; 1221359-2022-00682.

    Additional Manufacturer Narrative · 0

    INVESTIGATION REPORT: TESTING WAS PERFORMED IN TRIPLICATE AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 157899A 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 157899A AND DEVICE PART NUMBER 195-430WL / LOT 152969. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED THREE FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST, USING UNKNOWN SAMPLE TYPES. THE FIRST ANTIGEN SELF TEST WAS PERFORMED ON (B)(6) 2022 WHICH GENERATED A POSITIVE RESULT. THE SECOND ANTIGEN SELF TEST WAS PERFORMED ON THE SAME DAY, (B)(6) 2022 WHICH GENERATED A POSITIVE RESULT. CONFIRMATION PCR TESTING WAS PERFORMED BY A DOCTOR AT A HOSPITAL'S URGENT CARE ON (B)(6) 2022, USING AN UNKNOWN SAMPLE TYPE, WHICH GENERATED A NEGATIVE RESULT. THE CONSUMER THEN TOOK A THIRD ANTIGEN SELF TEST AFTER OBTAINING THE PCR TEST ON (B)(6) 2022, USING AN UNKNOWN SAMPLE TYPE WHICH GENERATED A POSITIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED. THIS MANUFACTURER REPORT ADDRESSES FALSE POSITIVE RESULT 1 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975272 BINAXNOW COVID-19 ANTIGEN SELF TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 157899A 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male