BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG CARD

    MDR report key: 10804319 · Received November 6, 2020

    Report

    Report Number
    1221359-2020-00327
    Event Type
    Malfunction
    Date Received
    November 6, 2020
    Date of Event
    October 12, 2020
    Report Date
    November 6, 2020
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    10811877011290
    PMA / PMN Number
    EUA202537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 M124858 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 124858 AND DEVICE PART NUMBER 195-430H / LOT 124431 WERE REVIEWED. THESE LOTS MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS CONFLICTING OR FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, FALSE AND CONFLICTING RESULTS) RELATED TO KIT LOT M124858 SHOW THAT THE COMPLAINT RATE IS (B)(4). 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 CARD ASSAY PERFORMED ON (B)(6) 2020. INFORMATION ON SAMPLE COLLECTION WAS NOT PROVIDED. THE CUSTOMER REPORTED A POSITIVE RESULT ON ONE BINAXNOW COVID-19 AG CARD. REPEAT TESTING ON A BINAXNOW COVID-19 AG CARD GENERATED A NEGATIVE RESULT. CONFIRMATION TESTING INFORMATION WAS NOT PROVIDED. THE CUSTOMER CONFIRMED THERE WAS NO DEATH BASED ON THE TEST RESULTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING SYMPTOMS, IMPACT, TREATMENT AND OUTCOME, WAS PROVIDED. ATTEMPTS TO GAIN FURTHER INFORMATION WERE UNSUCCESSFUL. PER BINAXNOW COVID-19 AG CARD PRODUCT INSERT INTENDED USE: POSITIVE RESULTS INDICATE THE PRESENCE OF VIRAL ANTIGENS, BUT CLINICAL CORRELATION WITH PATIENT HISTORY AND OTHER DIAGNOSTIC INFORMATION IS NECESSARY TO DETERMINE INFECTION STATUS. NEGATIVE RESULTS FROM PATIENTS WITH SYMPTOM ONSET BEYOND SEVEN DAYS 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. PER BINAXNOW COVID-19 AG CARD PRODUCT INSERT PRECAUTIONS AND LIMITATIONS: INADEQUATE OR INAPPROPRIATE SAMPLE COLLECTION, STORAGE, AND TRANSPORT MAY YIELD FALSE TEST RESULTS. FALSE NEGATIVE RESULTS CAN OCCUR IF THE SAMPLE SWAB IS NOT ROTATED (TWIRLED) PRIOR TO CLOSING THE CARD. FALSE RESULTS MAY OCCUR IF SPECIMENS ARE TESTED PAST 1 HOUR OF COLLECTION. SPECIMENS SHOULD BE TESTED AS QUICKLY AS POSSIBLE AFTER SPECIMEN COLLECTION. FALSE NEGATIVE RESULTS MAY OCCUR IF INADEQUATE EXTRACTION BUFFER IS USED (E.G.,<6 DROPS). FALSE NEGATIVE RESULTS MAY OCCUR IF SWABS ARE STORED IN THEIR PAPER SHEATH AFTER SPECIMEN COLLECTION. THE PRESENCE OF MUPIROCIN MAY INTERFERE WITH THE BINAXNOW COVID-19 AG TEST AND MAY CAUSE FALSE NEGATIVE RESULTS. UNEXPLAINED CONFLICTING RESULTS SHALL BE REPORTED AS A MALFUNCTION AS IT IS UNKNOWN WHICH RESULT IS CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265650 BINAXNOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 124858 10811877011290

    Patients

    Seq Age Sex Outcome Treatment
    1