BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG CARD

    MDR report key: 11204685 · Received January 20, 2021

    Report

    Report Number
    1221359-2021-00205
    Event Type
    Malfunction
    Date Received
    January 20, 2021
    Date of Event
    December 22, 2020
    Report Date
    February 9, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    PMA / PMN Number
    EUA202537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN D4: LOT NUMBER EXPIRATION DATE AND UDI AND H4. THE MANUFACTURING BATCH RECORDS AND QUALITY CONTROL RELEASE TESTING FOR KIT PART NUMBER: 195-000 / LOT: 130322 AND TEST BASE PART NUMBER: 195-430 H/ LOT: 128924 WERE REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. 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 SAMPLES.

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 130322 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 130322 SHOWED THAT THE COMPLAINT RATE IS (B)(4). THE AVAILABLE EVIDENCE SUGGESTS THAT THIS DEVICE LOT IS PERFORMING WITHIN THE STATEMENTS MADE WITHIN PACKAGE INSERT RELATED TO % TEST AGREEMENT WITH THE EXPECTED RESULTS BY SAMPLE CONCENTRATION. INVESTIGATION IS NOT YET COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT CONTAINING THE INFORMATION WILL SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY EIGHT (8) FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 AG TEST. THE CUSTOMER REPORTED NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 AG TESTS PERFORMED ON (B)(6) 2020. THE KNITTED SWABS COLLECTED SPECIMENS FROM BOTH NOSTRILS. THE CUSTOMER CONFIRMED THAT THE TEST PROCEDURE WAS THE SAME FOR EACH PATIENT. SIX (6) DROPS OF EXTRACTION REAGENT WAS ADDED TO THE TEST. IMMEDIATELY FOLLOWING, THE SWAB WAS INSERTED INTO THE TEST CARD AND THE SWAB WAS ROTATED CLOCKWISE THREE (3) TO FOUR (4) TIMES. FIFTEEN MINUTES LATER, THE TEST CARDS READ NEGATIVE RESULTS. REPEAT TESTING WITH THE BINAXNOW COVID-19 AG TEST ALSO GENERATED NEGATIVE RESULTS. THE CUSTOMER REPORTED THAT THE POSITIVE CONTROL SWABS FOR BINAXNOW COVID-19 AG TEST CARDS CAME BACK NEGATIVE. CONFIRMATION TESTING ON NASAL SWABS WITH IN-HOUSE SOLARIS PCR PERFORMED THE SAME DAY GENERATED POSITIVE RESULTS (CT VALUES NOT PROVIDED). ADDITIONAL CONFIRMATION TESTING WITH PCR WAS PERFORMED AT AN EXTERNAL LABORATORY (SAMPLES COLLECTED (B)(6) 2020; RESULTS NOT PROVIDED). THE CUSTOMER CONFIRMED THERE WAS NO DEATH OR SERIOUS INJURY BASED ON THE BINAXNOW COVID-19 AG TEST RESULTS. THE PATIENTS' TREATMENT WAS IMPACTED AND/OR DELAYED WHILE WAITING ON ADDITIONAL TEST RESULTS. IN ADDITION, NEGATIVE COVID-19 TEST RESULTS WERE REPORTED TO THE PATIENTS, SO OTHERS COULD HAVE BEEN EXPOSED. ALL THE PATIENTS HAD BEEN SYMPTOMATIC (INCLUDING, BUT LIMITED TO, COUGH, FEVER, LOSS OF TASTE) FOR THREE (3) TO FIVE (5) DAYS AT THE TIME OF TESTING. THE PATIENTS DID NOT RECEIVE ANY MEDICAL TREATMENT BASED ON THE TEST RESULTS. NEGATIVE RESULTS SHOULD BE TREATED AS PRESUMPTIVE AND CONFIRMATION WITH A MOLECULAR ASSAY, IF NECESSARY, FOR PATIENT MANAGEMENT, MAY BE PERFORMED. NEGATIVE RESULTS DO NOT RULE OUT SARS-COV-2 INFECTION AND SHOULD NOT BE USED AS THE SOLE BASIS FOR TREATMENT OR PATIENT MANAGEMENT DECISIONS, INCLUDING INFECTION CONTROL DECISIONS. NEGATIVE RESULTS SHOULD BE CONSIDERED IN THE CONTEXT OF A PATIENT'S RECENT EXPOSURES, HISTORY AND THE PRESENCE OF CLINICAL SIGNS AND SYMPTOMS CONSISTENT WITH COVID-19. DUE TO THE RISK OF A FALSE NEGATIVE RESULT POTENTIALLY LEADING TO NO OR DELAYED TREATMENT, THIS EVENT SHALL BE CONSIDERED REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99178 BINAXNOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 130322

    Patients

    Seq Age Sex Outcome Treatment
    1