BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG CARD

    MDR report key: 13148017 · Received January 3, 2022

    Report

    Report Number
    1221359-2022-00001
    Event Type
    Malfunction
    Date Received
    January 3, 2022
    Report Date
    December 6, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    PMA / PMN Number
    EUA202537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 0

    THE REQUIRED INTAKE INFORMATION TO ENABLE FURTHER INVESTIGATION, 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 THE STATEMENTS MADE IN THE PACKAGE INSERT. IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUES AS NO INFORMATION WAS PROVIDED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE CORRECTED DATA AND ADDITIONAL INFORMATION. PLEASE SEE UPDATES FIELDS: D2, D3,G1, G3 AND G4.

    Description of Event or Problem · 0

    ABBOTT RAPID DX NORTH AMERICA RECEIVED AN ARTICLE TITLED "IMPLEMENTATION AND ACCURACY OF BINAXNOW RAPID ANTIGEN COVID-19 TEST IN ASYMPTOMATIC AND SYMPTOMATIC POPULATIONS IN A HIGH-VOLUME SELF-REFERRED TESTING SITE." THE ARTICLE STATES THAT A STUDY WAS CONDUCTED TO EVALUATE THE SENSITIVITY AND SPECIFICITY, AS WELL AS THE IMPLEMENTATION OF A RAPID ANTIGEN TEST(BINAXNOW COVID-19 ANTIGEN TEST) IN THE MEDICAL FACILITY. THE ARTICLE STATES THAT THE STUDY INCLUDED 6,099 ADULTS AT A SELF-REFERRED WALKUP TESTING SITE. PARTICIPANTS WERE GROUPED BY SELF-REPORTED COVID-19 EXPOSURE AND SYMPTOM STATUS. MOST (89%) WERE ASYMPTOMATIC, OF WHOM 17% REPORTED POTENTIAL EXPOSURE. ACCORDING TO THE ARTICLE, A TOTAL OF 9,866 ADULTS UNDERWENT RT-PCR TESTING BETWEEN DECEMBER 23, 2020 AND JANUARY 11, 2021. OF THESE, 6,099 (61%) ENROLLED IN THIS STUDY OF WHICH 6,061 HAD VALID RAPID ANTIGEN TESTING AND RT-PCR RESULTS. THE ARTICLE STATES THAT AMONG THE STUDY SAMPLE, 3,223 PARTICIPANTS (53%) WERE FEMALE, 3,743 (61%) WERE WHITE, 1,110 (18%) WERE AFRICAN AMERICAN, AND THE MEDIAN AGE WAS (B)(6) (INTERQUARTILE RANGE IQR, 26-41 YEARS). THE ARTICLE STATES THAT THE SYMPTOM STATUS DATA FROM 6,098 PARTICIPANTS, 5,452 (89%) OF WHOM WERE ASYMPTOMATIC WAS OBTAINED. THE SYMPTOMATIC PARTICIPANTS WERE SLIGHTLY YOUNGER (34 VS. 35 YEARS) AND MORE FREQUENTLY NON-WHITE HISPANIC (5.9% VS. 3.7%). THE ARTICLE REPORTED THAT AMONG THE ASYMPTOMATIC PARTICIPANTS, 145 (2.7%) REPORTED LIVING WITH SOMEONE WITH CONFIRMED OR SUSPECTED COVID, 498 (9.1%) REPORTED BEING WITHIN 6 FEET OF SOMEONE 6 FEET OF SOMEONE WITH CONFIRMED OR SUSPECTED COVID-19 FOR GREATER THAN 15 MINUTES AND 248 (4.5%) REPORTED OTHER EXPOSURE TYPES. THE MEDIAN NUMBER OF DAYS SINCE EXPOSURE WAS 5 WITH PARTICIPANTS REPORTING ANY EXPOSURE. THE ARTICLE STATES THAT THE BINAXNOW RAPID ANTIGEN COVID-19 RESULT WERE READ AT 15 MINUTES. THE BINAXNOW RAPID ANTIGEN COVID-19 TEST HAD A SENSITIVITY OF 87% IN SYMPTOMATIC AND 71% ASYMPTOMATIC INDIVIDUALS WHEN PERFORMED BY HEALTH CARE WORKERS IN A HIGH-THROUGHPUT SETTING. THE OVERALL TEST SENSITIVITY COMPARED WITH REFERENCE LABORATORY REVERSE-TRANSCRIPTION (RT) PCR TESTING WAS 81% (95% CONFIDENCE INTERVAL CI 75%, 86%). THE ARTICLE REPORTED THIS WAS HIGHER IN SYMPTOMATIC (87%; 95% CI 80%, 91%) THAN ASYMPTOMATIC (71%; 95% CI 61%, 80%) INDIVIDUALS. THE SENSITIVITY WAS 82% (95% CI 66%, 91%) FOR ASYMPTOMATIC INDIVIDUALS WITH POTENTIAL EXPOSURE AND 64% (95% CI 51%, 76%) FOR THOSE WITH NO EXPOSURE. SPECIFICITY WAS GREATER THAN 99% FOR ALL GROUPS. THE COVID-19 PREVALENCE RATE WAS 3.7% (222/6,061) OVERALL, 1.6% (87/5,418) FOR ASYMPTOMATIC INDIVIDUALS, AND 21% (135/642) FOR SYMPTOMATIC INDIVIDUALS. THE ARTICLE STATES THAT THE BINAXNOW HAS HIGH ACCURACY AMONG SYMPTOMATIC INDIVIDUALS. IN CONCLUSION THE REPORTED THAT THE BINAXNOW RAPID ANTIGEN TEST MEETS THIS 70% THRESHOLD AND MAY OFFER A PRACTICAL ALTERNATIVE TO RT-PCR IN THIS POPULATION WHEN RT-PCR IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81469 BINAXNOW COVID-19 AG CARD CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown