BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 18610910 · Received January 30, 2024

    Report

    Report Number
    1221359-2024-00123
    Event Type
    Malfunction
    Date Received
    January 30, 2024
    Date of Event
    January 12, 2024
    Report Date
    March 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

    D4-UDI:(B)(4) THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. SINGLE USE; DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    D4(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. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 224083 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2024 ON A NASAL SAMPLE. INITIAL TESTING WAS PERFORMED ON (B)(6) 2024 USING A BINAXNOW COVID-19 ANTIGEN SELF-TEST WHICH GENERATED A POSITIVE RESULT. THE CONSUMER INDICATED THEY WERE EXPERIENCING SYMPTOMS SUCH AS NASAL DRIP, LOSS OF SMELL AND LOSS OF TASTE. THE CONSUMER WAS PROVIDED PAXLOVID. THE CONSUMER CONFIRMED THERE WAS NO HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CONSUMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN TREATMENT.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2024 ON A NASAL SAMPLE. INITIAL TESTING WAS PERFORMED ON (B)(6) 2024 USING A BINAXNOW COVID-19 ANTIGEN SELF-TEST WHICH GENERATED A POSITIVE RESULT. THE CONSUMER INDICATED THEY WERE EXPERIENCING SYMPTOMS SUCH AS NASAL DRIP, LOSS OF SMELL AND LOSS OF TASTE. THE CONSUMER WAS PROVIDED PAXLOVID. THE CONSUMER CONFIRMED THERE WAS NO HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CONSUMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415159 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 81 YR Male