BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 15825733 · Received November 18, 2022

    Report

    Report Number
    1221359-2022-10166
    Event Type
    Malfunction
    Date Received
    November 18, 2022
    Date of Event
    November 1, 2022
    Report Date
    January 31, 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
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 212603 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: 212603, TEST BASE PART NUMBER 195-430H / LOT: 206902. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 212603 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 ISSUES INCLUDING THE SELF-TEST USER PERFORMANCE, INTERPRETATION OF THE RESULT, OR 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 OR UPON RECEIPT OF NEW INFORMATION. SINGLE USE, DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED FALSE NEGATIVE RESULTS WITH THE BINAXNOW ANTIGEN SELF-TEST PERFORMED ON TWO DAYS USING ONE LOT. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF THREE (3). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2022. CONFIRMATION TESTING USING AN UNKNOWN BRAND OF ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2022 GENERATED A POSITIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED FALSE NEGATIVE RESULTS WITH THE BINAXNOW ANTIGEN SELF-TEST PERFORMED ON TWO DAYS USING ONE LOT. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF THREE (3). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2022. CONFIRMATION TESTING USING AN UNKNOWN BRAND OF ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2022 GENERATED A POSITIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229448 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 212603 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female