BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 17862448 · Received October 3, 2023

    Report

    Report Number
    1221359-2023-01481
    Event Type
    Malfunction
    Date Received
    October 3, 2023
    Date of Event
    September 26, 2023
    Report Date
    October 11, 2023
    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

    THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION OR UPON RECEIPT OF NEW INFORMATION. H3 OTHER TEXT : SINGLE-USE, DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    D4 UDI: (B)(4). TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 224083 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 224083, TEST BASE PART NUMBER 195-430H / LOT 220038. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. (B)(4). IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. H3 OTHER TEXT : SINGLE-USE, DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST PERFORMED ON (B)(6) 2023. CONFIRMATION RAPID PCR TESTING WAS PERFORMED AT THE PRIMARY CARE FACILITY ON (B)(6) 2023 AND GENERATED A NEGATIVE RESULT. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST PERFORMED ON (B)(6) 2023. CONFIRMATION RAPID PCR TESTING WAS PERFORMED AT THE PRIMARY CARE FACILITY ON (B)(6) 2023 AND GENERATED A NEGATIVE RESULT. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1761389 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 224083 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown