BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAX NOW COVID-19 AG CARD KIT 40T EUA

    MDR report key: 17186710 · Received June 22, 2023

    Report

    Report Number
    1221359-2023-01239
    Event Type
    Malfunction
    Date Received
    June 22, 2023
    Date of Event
    March 5, 2023
    Report Date
    June 22, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    10811877011290
    PMA / PMN Number
    EUA202537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 192453 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 195-000 / LOT 192453, TEST BASE PART NUMBER 195-430H / LOT 188883. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 192453 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 BE RELATED TO THE SPECIFIC PATIENT SAMPLES. H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FOUR (4) FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG CARD FOR MULTIPLE TESTS PERFORMED ON THE SAME PATIENT OVER TWO DATES. THIS MFR. REPORT ADDRESSES TEST TWO (2) OF FOUR (4). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG CARD PERFORMED ON (B)(6) 2023 ON A NASAL SAMPLE. CONFIRMATION PCR TESTING (UNKNOWN PLATFORM) WAS PERFORMED ON A NASAL SAMPLE AND GENERATED NEGATIVE RESULTS. THE CUSTOMER STATED THE PATIENT WAS PLACED IN ISOLATION FOR A WEEK. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1061812 BINAX NOW COVID-19 AG CARD KIT 40T EUA CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 192453 10811877011290

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown