BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 16132813 · Received January 10, 2023

    Report

    Report Number
    1221359-2023-00060
    Event Type
    Malfunction
    Date Received
    January 10, 2023
    Date of Event
    December 21, 2022
    Report Date
    February 28, 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

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 182479 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: 182479, TEST BASE PART NUMBER 195-430H / LOT: 180011. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 182479 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD HAVE POSSIBLE BEEN RELATED TO THE PATIENT SPECIFIC SAMPLE. B5: DATE OF CONFIRMATION PCR TEST ADDED TO EVENT DESCRIPTION. H3 OTHER TEXT : SINGLE USE DEVICE, DISCARDED.

    Additional Manufacturer Narrative · 0

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. SINGLE USE DEVICE, DISCARDED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED A FALSE NEGATIVE TEST RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2022. ADDITIONAL TESTING WAS PERFORMED USING ANOTHER BRAND OF ANTIGEN TEST THAT GENERATED A POSITIVE RESULT. CONFIRMATORY TESTING WAS ALSO CONDUCTED USING AN UNKNOWN PCR PLATFORM PERFORMED ON (B)(6) 2022, ALSO GENERATING A POSITIVE RESULT. THE CUSTOMER STATED THEY WERE SYMPTOMATIC ONE DAY PRIOR TO TESTING. 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

    CUSTOMER REPORTED A FALSE NEGATIVE TEST RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6)2022. ADDITIONAL TESTING WAS PERFORMED USING ANOTHER BRAND OF ANTIGEN TEST THAT GENERATED A POSITIVE RESULT. CONFIRMATORY TESTING WAS ALSO CONDUCTED USING AN UNKNOWN PCR PLATFORM PERFORMED ON AN UNKNOWN DATE, ALSO GENERATING A POSITIVE RESULT. THE CUSTOMER STATED THEY WERE SYMPTOMATIC ONE DAY PRIOR TO TESTING. 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
    1883859 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 182479 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female