BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAX NOW COVID-19 AG CARD

    MDR report key: 11316822 · Received February 11, 2021

    Report

    Report Number
    1221359-2021-00270
    Event Type
    Malfunction
    Date Received
    February 11, 2021
    Date of Event
    December 7, 2020
    Report Date
    May 12, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH INC.
    Product Code
    QKP
    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 · 0

    ADDITIONAL/CORRECTED INFORMATION: D3, D4, G1 H10: THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST KIT PART NUMBER 195-000/LOT:133348, TEST BASE PART NUMBER 195-430 / LOT: 131148. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. IN CONCLUSION,ABBOTT DIAGNOSTICS SCARBOROUGH 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

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED AFTER COMPLETION. PLEASE SEE RELATED MFR REPORT #S:1221359-2021-00276 AND 1221359-2021-00277.

    Description of Event or Problem · 1

    A CUSTOMER SENT A CUMULATIVE REPORT OF THREE FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY. THIS REPORT REPRESENTS PATIENT ONE OF THREE. THE CUSTOMER REPORTED A POSITIVE RESULT FROM A DIRECT KNITTED NASAL SWAB OF BOTH NOSTRILS WITH THE BINAXNOW COVID-19 AG CARD ASSAY PERFORMED ON THE MORNING OF (B)(6) 2020. PCR CONFIRMATION TESTING FROM A NASAL SAMPLE PERFORMED ON (B)(6) 2020 (PLATFORM NOT SPECIFIED) GENERATED NEGATIVE RESULTS (CT VALUES NOT PROVIDED). THE PATIENT DID NOT HAVE ANY SYMPTOMS AND WAS SENT HOME TO QUARANTINE. THE CUSTOMER CONFIRMED THERE WAS NO DEATH OR SERIOUS INJURY AND TREATMENT WAS NOT IMPACTED/DELAYED. POSITIVE RESULTS ARE INDICATIVE OF THE PRESENCE OF SARS-COV-2 RNA; CLINICAL CORRELATION WITH PATIENT HISTORY AND OTHER DIAGNOSTIC INFORMATION IS NECESSARY TO DETERMINE PATIENT INFECTION STATUS. POSITIVE RESULTS DO NOT RULE OUT BACTERIAL INFECTION OR CO-INFECTION WITH OTHER VIRUSES. DUE TO THE HIGH SENSITIVITY OF THE ASSAYS RUN ON THE INSTRUMENT, CONTAMINATION OF THE WORK AREA WITH PREVIOUS POSITIVE SAMPLES MAY CAUSE FALSE POSITIVE RESULTS. HANDLE SAMPLES ACCORDING TO STANDARD LABORATORY PRACTICES. CLEAN INSTRUMENTS AND SURROUNDING SURFACES ACCORDING TO INSTRUCTIONS PROVIDED IN THE CLEANING SECTION OF THE INSTRUMENT USER MANUAL. DUE TO THE RISK OF A FALSE POSITIVE RESULT LEADING TO POSSIBLE EXPOSURE TO COVID-19 THROUGH THE QUARANTINE OF THE FALSE POSITIVE PATIENT WITH TRUE POSITIVE PATIENT(S), DELAYED EMERGENCY TREATMENT AND/OR INAPPROPRIATE TREATMENT WITH ANTIVIRAL THERAPY, THE INCIDENT SHALL BE CONSIDERED REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212976 BINAX NOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR