BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 15997789 · Received December 16, 2022

    Report

    Report Number
    1221359-2022-10341
    Event Type
    Malfunction
    Date Received
    December 16, 2022
    Date of Event
    December 4, 2022
    Report Date
    February 10, 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 OR UPON RECEIPT OF NEW INFORMATION. SINGLE-USE; DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 210924 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: 210924, TEST BASE PART NUMBER 195-430H / LOT: 207165. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE OR FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 210924 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 BEEN RELATED TO THE SPECIFIC PATIENT SAMPLE. H3 OTHER TEXT : SINGLE-USE; DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A CONFLICTING RESULT WITH THE BINAXNOWCOVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2022. PER THE CONSUMER, THE TEST GENERATED A NEGATIVE RESULT AT THE 15-MINUTE READ MARK AND A POSITIVE RESULT AT THE 25-MINUTE READ MARK. THERE WAS NO REPORTED PATIENT IMPACT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A CONFLICTING RESULT WITH THE BINAXNOWCOVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2022. PER THE CONSUMER, THE TEST GENERATED A NEGATIVE RESULT AT THE 15-MINUTE READ MARK AND A POSITIVE RESULT AT THE 25-MINUTE READ MARK. THERE WAS NO REPORTED PATIENT IMPACT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2699847 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 210924 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Female