BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG CARD

    MDR report key: 13456386 · Received February 4, 2022

    Report

    Report Number
    1221359-2022-00641
    Event Type
    Malfunction
    Date Received
    February 4, 2022
    Date of Event
    September 18, 2021
    Report Date
    June 21, 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 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. THE FOLLOWING MFR REPORT NUMBERS ARE RELATED TO THIS REPORT: 1221359-2022-00632, 1221359-2022-00633, 1221359-2022-00634, 1221359-2022-00635, 1221359-2022-00636, 1221359-2022-00637, 1221359-2022-00639, 1221359-2022-00640, 1221359-2022-00642, 1221359-2022-00643, 1221359-2022-00644, 1221359-2022-00645, 1221359-2022-00646, 1221359-2022-00647.

    Additional Manufacturer Narrative · 0

    TESTED THE BINAXNOW COVID-19 AG CARD RETAIN KIT LOT 132164 WITH COVID-19 LOD AND BLANK PATIENT SWABS. ALL TESTS WERE RUN IN TRIPLICATE, WERE VALID, AND PERFORMED AS EXPECTED. NO FALSE POSITIVE RESULTS WERE OBSERVED, AND THE CUSTOMERS COMPLAINT WAS NOT REPLICATED. THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR KIT PART NUMBER 195-000 LOT 132164 AND DEVICE PART NUMBER 195-430H / LOT 129781A. QUALITY CONTROL RELEASE TESTING MET SPECIFICATIONS AND THERE WERE NO FALSE POSITIVE RESULTS OBSERVED. THE CURRENT OVERALL INCIDENT RATE FOR FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) FOR THIS SPECIFIC LOT BASED ON THE TOTAL QUANTITY OF DEVICES MANUFACTURED FOR DISTRIBUTION IS (B)(4).. BASED ON THE EVIDENCE AVAILABLE, IT INDICATES THAT THIS DEVICE LOT IS PERFORMING WITHIN LABEL CLAIMS. 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 FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG CARD TEST FOR MULTIPLE TESTS. THIS MFR. REPORT ADDRESSES TEST 9 OF 15. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG CARD TEST PERFORMED ON (B)(6) 2021 ON A NASAL SAMPLE SWAB. REPEAT TESTING WAS NOT PERFORMED. PCR CONFIRMATION TESTING WITH A PERKINELMER PLATFORM WAS PERFORMED AND GENERATED A NEGATIVE RESULT. THE CUSTOMER STATED THE PATIENT WAS ASYMPTOMATIC. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1316006 BINAXNOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 132164

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male