BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG CARD

    MDR report key: 10864913 · Received November 18, 2020

    Report

    Report Number
    1221359-2020-00393
    Event Type
    Malfunction
    Date Received
    November 18, 2020
    Date of Event
    October 22, 2020
    Report Date
    November 18, 2020
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    PMA / PMN Number
    EUA202537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 1

    THE REQUIRED INFORMATION TO ENABLE FURTHER INVESTIGATION AT ABBOTT DIAGNOSTICS (B)(4), INC., SUCH AS THE KIT'S LOT NUMBER, WAS NOT PROVIDED AND AN INVESTIGATION WAS NOT ABLE TO BE PERFORMED. NOTWITHSTANDING, A REVIEW OF COMPLAINTS' TREND REVEALS THAT ALL LOTS WITHIN EXPIRY DATING ARE PERFORMING ACCORDING TO LABEL CLAIMS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED CONFLICTING RESULTS ON THE BINAXNOW COVID-19 ANTIGEN CARD AND THE ID NOW COVID-19 ASSAY (REFER TO MFR REPORT 1221359-2020-00392). THE CUSTOMER REPORTED A NEGATIVE RESULT ON A NASOPHARYNGEAL SWAB WITH THE BINAXNOW COVID-19 ANTIGEN CARD TEST PERFORMED (B)(6) 2020. AN HOUR LATER, A NASOPHARYNGEAL SWAB WITH THE ID NOW COVID-19 ASSAY GENERATED POSITIVE RESULTS. SWAB TYPE AND VIRAL TRANSPORT MEDIA USE INFORMATION WAS NOT PROVIDED. INFORMATION REGARDING CONFIRMATION TESTING WAS NOT PROVIDED. THE PATIENT TESTED AND CONFIRMED POSITIVE BY PCR FOR COVID-19 TWELVE DAYS PRIOR. NO ADDITIONAL PATIENT INFORMATION, INCLUDING SYMPTOMS, TREATMENT, AND OUTCOME, WAS PROVIDED. 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
    1327982 BINAXNOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1