BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 4CT

    MDR report key: 19905517 · Received August 5, 2024

    Report

    Report Number
    1221359-2024-00528
    Event Type
    Malfunction
    Date Received
    August 5, 2024
    Date of Event
    July 29, 2024
    Report Date
    September 25, 2024
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    00811877011729
    PMA / PMN Number
    EUA210264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION OR UPON RECEIPT OF NEW INFORMATION.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 870976A 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 195-180/ LOT 870976A AND TEST BASE PART NUMBER 195-430WJR/ LOT 870976. 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 870976A 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.

    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) 2024 ON A NASAL SAMPLE. THE CONSUMER PERFORMED PRIOR TESTING WITH THE BINAXNOW SELF-TEST ON (B)(6) 2024 AND AN UNKNOWN DATE AND BOTH TESTS GENERATED NEGATIVE RESULTS. THE CONSUMER PERFORMED ADDITIONAL TESTING WITH AN IHEALTH COVID TEST ON (B)(6) 2024 AND GENERATED A NEGATIVE RESULT. ON (B)(6) 2024, THE CONSUMER ALREADY HAD SYMPTOMS LIKE FEVER, SORE THROAT, AND HEAD CONGESTION. THE CONSUMER CONTACTED HIS DOCTOR BUT WAS NOT PROVIDED MEDICATION. ON (B)(6) 2024, THE CONSUMER WAS EXPERIENCING SYMPTOMS OF HEAD CONGESTION AND ACHY BODY. THE CONSUMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CONSUMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THEIR TREATMENT.

    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) 2024 ON A NASAL SAMPLE. THE CONSUMER PERFORMED PRIOR TESTING WITH THE BINAXNOW SELF-TEST ON (B)(6) 2024 AND AN UNKNOWN DATE AND BOTH TESTS GENERATED NEGATIVE RESULTS. THE CONSUMER PERFORMED ADDITIONAL TESTING WITH AN IHEALTH COVID TEST ON (B)(6) 2024 AND GENERATED A NEGATIVE RESULT. ON (B)(6) 2024, THE CONSUMER ALREADY HAD SYMPTOMS LIKE FEVER, SORE THROAT, AND HEAD CONGESTION. THE CONSUMER CONTACTED HIS DOCTOR BUT WAS NOT PROVIDED MEDICATION. ON (B)(6) 2024, THE CONSUMER WAS EXPERIENCING SYMPTOMS OF HEAD CONGESTION AND ACHY BODY. THE CONSUMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CONSUMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THEIR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2253075 BINAXNOW COVID-19 AG SELF TEST 4CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 870976A 00811877011729

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male