BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG CARD

    MDR report key: 11007762 · Received December 15, 2020

    Report

    Report Number
    1221359-2020-00431
    Event Type
    Malfunction
    Date Received
    December 15, 2020
    Date of Event
    November 16, 2020
    Report Date
    December 14, 2020
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA202537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 129436 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING BATCH RECORDS AND QUALITY CONTROL RELEASE TESTING FOR KIT PART NUMBER 195-000 / LOT 129436 AND DEVICE PART NUMBER 195-430H / LOT 128113A WERE REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS CONFLICTING RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 129436 SHOWED THAT THE COMPLAINT RATES ARE (B)(4) FOR BOTH. ABBOTT DIAGNOSTICS (B)(4), INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED CONFLICTING RESULTS WITH THE BINAXNOW COVID-19 AG TEST. THE CUSTOMER REPORTED A POSITIVE RESULT, FIRST INTERPRETED AS INVALID, WITH THE BINAXNOW COVID-19 AG TEST PERFORMED (B)(6) 2020. THE KITTED NASAL SWAB WAS ROTATED FIVE TIMES INSIDE THE MOST CONGESTED NOSTRIL. IMMEDIATELY FOLLOWING, SIX DROPS OF EXTRACTION REAGENT WERE ADDED TO THE TEST CARD. THEN, THE SWAB WAS INSERTED INTO THE BOTTOM OF THE TEST CARD AND PUSHED UP AND ROTATED THREE (3) TIMES CLOCKWISE. FIFTEEN MINUTES LATER, A FAINT PINK ON THE BOTTOM LINE WAS PRESENT, A POSITIVE RESULT. REPEAT TESTING WITH THE BINAXNOW COVID-19 AG TEST GENERATED NEGATIVE RESULTS. CONFIRMATION TESTING WAS NOT PERFORMED. THE CUSTOMER CONFIRMED THERE WAS NO DEATH OR SERIOUS INJURY BASED ON BINAXNOW COVID-19 AG RESULT. THE PATIENT WAS ASYMPTOMATIC, ASIDE FROM A RUNNY/CONGESTED NOSE, AT THE TIME OF TESTING. 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
    1472339 BINAXNOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 129436 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1