BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG CARD

    MDR report key: 14219748 · Received April 27, 2022

    Report

    Report Number
    1221359-2022-02380
    Event Type
    Malfunction
    Date Received
    April 27, 2022
    Date of Event
    October 19, 2021
    Report Date
    May 25, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    10811877011290
    PMA / PMN Number
    EUA202537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST KIT PART NUMBER 195-000/ LOT 142060 AND TEST BASE PART NUMBER 195-430H / LOT 136894A.. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE AND FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 142060 SHOWED THAT THE COMPLAINT RATE IS (B)(4) AND (B)(4) RESPECTIVELY . 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED CONFLICTING RESULTS WITH THE BINAXNOW COVID-19 AG CARD FOR TWO TESTS. THIS MFR. REPORT ADDRESSES TEST 2 OF 2. THE CUSTOMER REPORTED CONFLICTING RESULTS WITH THE BINAXNOW COVID-19 AG CARD PERFORMED ON (B)(6) 2021. THE BINAXNOW COVID-19 AG CARD PERFORMED ON (B)(6) 2021 DISPLAYED POSITIVE AND NEGATIVE RESULTS WITHIN THE RESULT READING TIME FRAME. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1841747 BINAXNOW COVID-19 AG CARD CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 142060 10811877011290

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown