BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 16685051 · Received April 5, 2023

    Report

    Report Number
    1221359-2023-00582
    Event Type
    Malfunction
    Date Received
    April 5, 2023
    Date of Event
    March 29, 2023
    Report Date
    June 15, 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 ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 221089 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 221089, TEST BASE PART NUMBER 195-430WL / LOT 217318. 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 221089 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE.

    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 A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2023 USING A NASAL SAMPLE WITH THE KIT SWAB. PER THE CONSUMER, THEY INSERTED THE SWAB PRIOR TO ADDING THE REAGENT DROPS. THEY THEN REMOVED THE SWAB, ADDED THE REAGENT, AND REINSERTED THE SWAB. ADDITIONALLY, THE CONSUMER STATED THEY MOVED THE TEST CARD DURING THE 15 TO 30 MINUTE READ WINDOW. A TEST WAS PERFORMED ON (B)(6) 2023 USING AN UNKNOWN TESTING METHOD FROM ANOTHER BRAND AND GENERATED A POSITIVE RESULT. THE CONSUMER CONFIRMED THERE WAS NO IMPACT.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2023 USING A NASAL SAMPLE WITH THE KIT SWAB. PER THE CONSUMER, THEY INSERTED THE SWAB PRIOR TO ADDING THE REAGENT DROPS. THEY THEN REMOVED THE SWAB, ADDED THE REAGENT, AND REINSERTED THE SWAB. ADDITIONALLY, THE CONSUMER STATED THEY MOVED THE TEST CARD DURING THE 15 TO 30 MINUTE READ WINDOW. A TEST WAS PERFORMED ON (B)(6) 2023 USING AN UNKNOWN TESTING METHOD FROM ANOTHER BRAND AND GENERATED A POSITIVE RESULT. THE CONSUMER CONFIRMED THERE WAS NO IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2258539 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 221089 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female