BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF TEST OTC 2 TEST PACK

    MDR report key: 11871820 · Received May 24, 2021

    Report

    Report Number
    1221359-2021-01545
    Event Type
    Malfunction
    Date Received
    May 24, 2021
    Date of Event
    April 25, 2021
    Report Date
    November 23, 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

    22NOV2022 ST: CORRECTED G1 WITH ACCURATE MANUFACTURER CONTACT INFO. CORRECTED D3 WITH ACCURATE MANUFACTURER CONTACT INFO. CORRECTED G4 TO ACCURATE PMA/510(K) NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H10: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 152369 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: 152369, TEST BASE PART NUMBER 195-430WL/LOT: 152369 . 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 152369 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD POSSIBLY BE RELATED TO THE SPECIFIC PATIENT SAMPLE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST OTC 2 TEST PACK PERFORMED ON (B)(6) 2021. REPEAT TESTING WAS DONE THE SAME DAY AND GENERATED A POSITIVE RESULT. REPEAT TESTING WAS PERFORMED ON (B)(6) 2021 AND GENERATED NEGATIVE RESULTS. REPEAT TESTING WAS PERFORMED ON (B)(6) 2021 AND GENERATED NEGATIVE RESULTS. CONFIRMATION TESTING WAS PERFORMED WITH PCR AND GENERATED NEGATIVE RESULTS. THE CUSTOMER STATED THAT SHE HAD COVID IN THE PAST AND WAS NOW EXPOSED TO COVID BUT SHE HAD NO SYMPTOMS. NO ADDITIONAL INFORMATION, INCLUDING PATIENT TREATMENT AND OUTCOME WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765820 BINAXNOW COVID-19 ANTIGEN SELF TEST OTC 2 TEST PACK LATER FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 152369 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Female