BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 16963184 · Received May 19, 2023

    Report

    Report Number
    1221359-2023-01144
    Event Type
    Malfunction
    Date Received
    May 19, 2023
    Date of Event
    May 9, 2023
    Report Date
    June 14, 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 REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. SINGLE USE, DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 217759 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: 217759, TEST BASE PART NUMBER 195-430H/ LOT: 213684. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE AND FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 217759 SHOWED THAT THE COMPLAINT RATE IS (B)(4), RESPECTIVELY. ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD HAVE POSSIBLY BEEN RELATED TO THE SPECIFIC PATIENT SAMPLE.B5 H3 OTHER TEXT : SINGLE USE, DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED CONFLICTING RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST KIT PERFORMED ON (B)(6) 2023 ON A NASAL SAMPLE. ON (B)(6) 2023, THE FIRST TEST TAKEN GENERATED A POSITIVE RESULT, AND THE SECOND TEST, PERFORMED ON THE SAME DAY, GENERATED A NEGATIVE RESULT. ADDITIONAL TESTING WAS NOT PERFORMED. THE CONSUMER CONFIRMED THERE WAS NO HARM DUE TO THE TEST RESULTS AND CONFIRMED THERE WAS NO DELAY OR IMPACT IN TREATMENT.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED CONFLICTING RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST KIT PERFORMED ON (B)(6) 2023 ON A NASAL SAMPLE. ON (B)(6) 2023, THE FIRST TEST TAKEN GENERATED A POSITIVE RESULT, AND THE SECOND TEST, PERFORMED ON THE SAME DAY, GENERATED A NEGATIVE RESULT. ADDITIONAL TESTING WAS NOT PERFORMED. THE CUSTOMER WAS REPORTEDLY ASYMPTOMATIC BUT TESTED DUE TO POTENTIAL EXPOSURE AND A SPOUSE EXHIBITING SYMPTOMS. THE CONSUMER CONFIRMED THERE WAS NO HARM DUE TO THE TEST RESULTS AND CONFIRMED THERE WAS NO DELAY OR IMPACT IN TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853563 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 217759 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female