BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 16682550 · Received April 5, 2023

    Report

    Report Number
    1221359-2023-00575
    Event Type
    Malfunction
    Date Received
    April 5, 2023
    Date of Event
    March 21, 2023
    Report Date
    May 26, 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. H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 205117 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 KIT PART NUMBER 195-160/ LOT 205117 AND DEVICE PART NUMBER 195-430H/ LOT 200424. 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 205117 SHOWED THAT THE COMPLAINT RATE IS (B)(4)%. ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2023 ON A NASAL SAMPLE. REPEAT TESTING WAS PERFORMED VIA NASAL SAMPLE USING THE SECOND TEST FROM THE SAME KIT AND LOT NUMBER AND GENERATED A NEGATIVE RESULT. ADDITIONALLY, A THIRD UNKNOWN TEST WAS TAKEN THE SAME DAY ((B)(6) 2023) USING AN UNKNOWN SAMPLE TYPE AND ALSO GENERATED A NEGATIVE RESULT. CONFIRMATION TESTING WAS NOT PERFORMED. IT WAS REPORTED THAT DURING THE FIRST BINAXNOW COVID-19 ANTIGEN SELF-TEST, THE USER MOVED THE TEST DURING THE TESTING WINDOW; THE PACKAGE INSERT ADVISES NOT TO MOVE OR TOUCH THE TEST CARD DURING THE TESTING WINDOW. ADDITIONALLY, DURING HER SECOND BINAXNOW COVID-19 ANTIGEN SELF-TEST, THE CONSUMER ADDED SEVEN (7) DROPS OF REAGENT, RATHER THAN THE SIX (6) THAT ARE CALLED FOR WITHIN THE PACKAGE INSERT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2023 ON A NASAL SAMPLE. REPEAT TESTING WAS PERFORMED VIA NASAL SAMPLE USING THE SECOND TEST FROM THE SAME KIT AND LOT NUMBER AND GENERATED A NEGATIVE RESULT. ADDITIONALLY, A THIRD UNKNOWN TEST WAS TAKEN THE SAME DAY ((B)(6) 2023) USING AN UNKNOWN SAMPLE TYPE AND ALSO GENERATED A NEGATIVE RESULT. CONFIRMATION TESTING WAS NOT PERFORMED. IT WAS REPORTED THAT DURING THE FIRST BINAXNOW COVID-19 ANTIGEN SELF-TEST, THE USER MOVED THE TEST DURING THE TESTING WINDOW; THE PACKAGE INSERT ADVISES NOT TO MOVE OR TOUCH THE TEST CARD DURING THE TESTING WINDOW. ADDITIONALLY, DURING HER SECOND BINAXNOW COVID-19 ANTIGEN SELF-TEST, THE CONSUMER ADDED SEVEN (7) DROPS OF REAGENT, RATHER THAN THE SIX (6) THAT ARE CALLED FOR WITHIN THE PACKAGE INSERT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1349466 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 205117 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female