BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF TEST

    MDR report key: 13351179 · Received January 25, 2022

    Report

    Report Number
    1221359-2022-00547
    Event Type
    Malfunction
    Date Received
    January 25, 2022
    Date of Event
    December 29, 2021
    Report Date
    June 16, 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

    INVESTIGATION REPORT: TESTING WAS PERFORMED IN TRIPLICATE AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 170185 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 KIT PART NUMBER 195-160 LOT 170185 AND DEVICE PART NUMBER 195-430H/LOT 168267. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE AND FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 170185 SHOWED THAT THE COMPLAINT RATE IS 0.000% AND 0.001% RESPECTIVELY. 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

    CORRECTED DATA: H10: INVESTIGATION SUMMARY: INVESTIGATION SUMMARY SUBMITTED ON SUPPLEMENT ONE INCLUDED THE INCORRECT % FOR REPORTED FALSE POSITIVE PATIENT RESULTS. SEE BELOW FOR CORRECTED DATA: A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE AND FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 170185 SHOWED THAT THE COMPLAINT RATE IS 0.0003% AND 0.001% RESPECTIVELY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED CONFLICTING RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST ASSAY PERFORMED ON (B)(6) 2021 ON A DIRECT TESTED NASAL KITTED SWAB. THE CUSTOMER STATES THAT THEIR INITIAL BINAXNOW COVID-19 ANTIGEN SELF TEST PERFORMED ON (B)(6) 2021 AT 9:30AM EST GAVE NEGATIVE RESULTS. REPEAT TESTING PERFORMED THE SAME DAY AT 10:00PM EST GENERATED POSITIVE RESULTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775252 BINAXNOW COVID-19 ANTIGEN SELF TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC 170185 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female