BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 18329307 · Received December 14, 2023

    Report

    Report Number
    1221359-2023-01755
    Event Type
    Malfunction
    Date Received
    December 14, 2023
    Date of Event
    December 5, 2023
    Report Date
    January 17, 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

    D4: (B)(4) THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. H3 OTHER TEXT : OTHER - DEVICE NOT RETURNED; SINGLE USE DEVICE

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: E1 - FACILITY NAME. D4: UDI (B)(4). TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 197088 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 197088, TEST BASE PART NUMBER 195-430H / LOT 191526. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. (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 PATIENT SAMPLE. H3 OTHER TEXT : OTHER - DEVICE NOT RETURNED; SINGLE USE DEVICE.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED CONFLICTING RESULTS USING A BINAXNOW COVID-19 AG SELF TEST PERFORMED ON (B)(6) 2023 WITH A NASAL SWAB. THE CONSUMER INDICATED THAT THE SAMPLE LINE CHANGED FROM POSITIVE TO NEGATIVE WITHIN THE INSTRUCTED READ WINDOW OF 15-30 MINUTES. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION, INCLUDING PATIENT OUTCOME OR TREATMENT, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED CONFLICTING RESULTS USING A BINAXNOW COVID-19 AG SELF TEST PERFORMED ON (B)(6) 2023 WITH A NASAL SWAB. THE CONSUMER INDICATED THAT THE SAMPLE LINE CHANGED FROM POSITIVE TO NEGATIVE WITHIN THE INSTRUCTED READ WINDOW OF 15-30 MINUTES. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION, INCLUDING PATIENT OUTCOME OR TREATMENT, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1823942 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 197088 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male