BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF TEST OTC 2 TEST PACK

    MDR report key: 13119326 · Received December 30, 2021

    Report

    Report Number
    1221359-2021-03917
    Event Type
    Malfunction
    Date Received
    December 30, 2021
    Date of Event
    December 3, 2021
    Report Date
    June 9, 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

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 170055 WITH INTERNAL LIMIT OF DETECTION (LOD) POSITIVE QUALITY CONTROL X3 DEVICES AND NEGATIVE (BLANK) SWABS X3 DEVICES. ALL TESTS WERE VALID AND PERFORMED AS EXPECTED WITH NO CONFLICTING RESULTS REPLICATED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST KIT PART NUMBER 195-160 LOT 170055 AND DEVICE PART NUMBER 195-430H / LOT 168079. QUALITY CONTROL RELEASE TESTING MET SPECIFICATIONS WITH NO CONFLICTING RESULTS OBSERVED. THE CURRENT OVERALL INCIDENT RATE FOR FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) FOR THIS SPECIFIC LOT BASED ON THE TOTAL QUANTITY OF DEVICES MANUFACTURED FOR DISTRIBUTION IS(B)(4).BASED ON THE EVIDENCE AVAILABLE, IT INDICATES THAT THIS DEVICE LOT IS PERFORMING WITHIN LABEL CLAIMS. NO FURTHER ACTION IS REQUIRED. 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.

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A CONFLICTING RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST OTC 2 TEST PACK ON A NASAL SWAB SAMPLE. THE INITIAL TEST PERFORMED GENERATED A POSITIVE RESULT. REPEAT TESTING WAS PERFORMED THE FOLLOWING DAY ON A NASAL SWAB AND GENERATED A NEGATIVE RESULT. THE CONSUMER REPORTED THAT HE WAS SYMPTOMATIC TEN DAYS PRIOR TO TESTING. TECHNICAL SERVICES (TS) ADVISED TO OBTAIN CONFIRMATION TESTING. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2019801 BINAXNOW COVID-19 ANTIGEN SELF TEST OTC 2 TEST PACK LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 170055 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Male