BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 18729249 · Received February 19, 2024

    Report

    Report Number
    1221359-2024-00194
    Event Type
    Malfunction
    Date Received
    February 19, 2024
    Date of Event
    January 25, 2024
    Report Date
    February 19, 2024
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FDA UDI ¿ (B)(6) TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 226152 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 226152 AND TEST BASE PART NUMBER 195-430H/ LOT 222445. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 226152 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 HAVE POSSIBLY BEEN RELATED TO THE SPECIFIC PATIENT SAMPLE. H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED TWO FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6)2024 AND (B)(6)2024. THIS MANUFACTURER'S REPORT ADDRESSES TEST ONE (1) OF TWO (2). CONSUMER PERFORMED THE FIRST BINAXNOW TEST ON 25JAN2024 AND THE SECOND BINAXNOW TEST ON (B)(6)2024, BOTH GENERATED POSITIVE RESULTS. PCR CONFIRMATION TESTING (PLATFORM UNKNOWN) WAS PERFORMED AT A CLINIC ON 27JAN2024 AND GENERATED A NEGATIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495174 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 226152 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male