BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAX NOW COVID-19 AG CARD KIT 40T EUA

    MDR report key: 16088655 · Received January 3, 2023

    Report

    Report Number
    1221359-2023-00010
    Event Type
    Malfunction
    Date Received
    January 3, 2023
    Date of Event
    December 20, 2022
    Report Date
    February 23, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    10811877011290
    PMA / PMN Number
    EUA202537
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 192803 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 192803, TEST BASE PART NUMBER 195-430R/ LOT 189252. 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 192803 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FIVE (5) UNCONFIRMED FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG CARD ON (B)(6) 2022. THIS MFR. REPORT ADDRESSES TEST FOUR (4) OF FIVE (5). REPEAT TESTING AND CONFIRMATION TESTING WERE NOT PERFORMED. THE CUSTOMER PERFORMED THE TESTS ON ASYMPTOMATIC STAFF MEMBERS. THE TESTS WERE USED FOR TROUBLESHOOTING, NOT FOR CLINICAL PURPOSES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FIVE (5) UNCONFIRMED FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG CARD ON (B)(6) 2022. THIS MFR. REPORT ADDRESSES TEST FOUR (4) OF FIVE (5). REPEAT TESTING AND CONFIRMATION TESTING WERE NOT PERFORMED. THE CUSTOMER PERFORMED THE TESTS ON ASYMPTOMATIC STAFF MEMBERS. THE TESTS WERE USED FOR TROUBLESHOOTING, NOT FOR CLINICAL PURPOSES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524010 BINAX NOW COVID-19 AG CARD KIT 40T EUA CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 192803 10811877011290

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown