BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 16993968 · Received May 24, 2023

    Report

    Report Number
    1221359-2023-01155
    Event Type
    Malfunction
    Date Received
    May 24, 2023
    Date of Event
    May 17, 2023
    Report Date
    June 19, 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 (B)(6). ON RETAINED KIT LOT 211656 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: 211656, TEST BASE PART NUMBER 195-430H/ LOT: 208044. (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD POSSIBLY BE RELATED TO THE SPECIFIC PATIENT SAMPLE. 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. H3 OTHER TEXT : SINGLE USE, DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2023. INITIAL TESTING WAS PERFORMED USING AN UNKNOWN BRAND OF RAPID ANTIGEN TEST ON (B)(6) 2023 WHICH PRODUCED A POSITIVE RESULT. NO PCR WAS REPORTED TO HAVE BEEN PERFORMED. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2023. INITIAL TESTING WAS PERFORMED USING AN UNKNOWN BRAND OF RAPID ANTIGEN TEST ON (B)(6) 2023 WHICH PRODUCED A POSITIVE RESULT. NO PCR WAS REPORTED TO HAVE BEEN PERFORMED. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1897848 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 211656 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Female