BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BINAXNOW COVID-19 AG CARD

    MDR report key: 11248009 · Received January 28, 2021

    Report

    Report Number
    1221359-2021-00227
    Event Type
    Injury
    Date Received
    January 28, 2021
    Date of Event
    April 1, 2021
    Report Date
    March 30, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    10811877011290
    PMA / PMN Number
    EUA202537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL DATA: B3,D4,H4. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 138711 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 195-000 / LOT 138711, TEST BASE PART NUMBER 195-430H / LOT 134431A. 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 138711 SHOWED THAT THE COMPLAINT RATE IS 0.0004% (1/260000). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUEE; HOWEVER, IT COULD POSSIBLY BE RELATED TO THE SPECIFIC PATIENT SAMPLE.

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 138711 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 AND FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 138711 SHOWED THAT THE COMPLAINT RATES ARE (B)(4) FOR BOTH. 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. THE INVESTIGATION IS NOT YET COMPLETE. UPON COMPLETION, THE INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISCREPANT RESULTS WITH THE BINAXNOW COVID-19 AG TEST. THE CUSTOMER REPORTED A POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG TEST PERFORMED (B)(6) 2020. TWO REPEAT TESTS PERFORMED THAT SAME DAY WITH THE BINAXNOW COVID-19 AG TEST BOTH GENERATED NEGATIVE RESULTS. ALL THREE TESTS WERE PERFORMED BY THE USER ADDING SIX (6) DROPS OF EXTRACTION REAGENT TO THE TEST CARD, IMMEDIATELY INSERTING THE KNITTED NASAL SWAB INTO THE TEST CARD AND ROTATING THREE (3) TIMES CLOCKWISE, AND READING THE RESULTS AT FIFTEEN (15) MINUTES. NO INFORMATION REGARDING CONFIRMATION TESTING WAS PROVIDED. THE CUSTOMER CONFIRMED THERE WAS NO DEATH OR SERIOUS INJURY BASED ON THE BINAXNOW COVID-19 AG TEST RESULTS. THERE WAS NO DELAY OR IMPACT TO PATIENT TREATMENT. THE PATIENT WAS INSTRUCTED TO TREAT THIS THE RESULTS AS A POSITIVE FOR COVID-19 AND TO QUARANTINE. PER BINAX NOW COVID-19 AG CARD PRODUCT INSERT : POSITIVE RESULTS INDICATE THE PRESENCE OF VIRAL ANTIGENS. INADEQUATE OR INAPPROPRIATE SAMPLE COLLECTION, STORAGE, AND TRANSPORT MAY YIELD FALSE TEST RESULTS. CHANGING OF GLOVES BETWEEN HANDLING OF SPECIMENS SUSPECTED OF COVID-19 TO PREVENT CONTAMINATION. PER BINAX NOW COVID-19 AG CARD PRODUCT INSERT: 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. UNEXPLAINED CONFLICTING RESULTS SHALL BE REPORTED AS IT IS UNKNOWN WHICH RESULT IS CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144505 BINAXNOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 138711 10811877011290

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Female