BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAX NOW COVID-19 AG CARD

    MDR report key: 12286010 · Received August 6, 2021

    Report

    Report Number
    1221359-2021-02209
    Event Type
    Malfunction
    Date Received
    August 6, 2021
    Date of Event
    July 8, 2021
    Report Date
    December 18, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    PMA / PMN Number
    EUA202537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE INVESTIGATION CONCLUSION. PLEASE SEE UPDATES: G3, G6, H2 AND H6. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 195-160/ LOT 153364 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST KIT PART NUMBER 190-430H / LOT 148134 . TEST BASE PART NUMBER 190-100 / LOT 153364. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 153364 SHOWED THAT THE COMPLAINT RATE IS (B)(4). IN CONCLUSION, THE MANUFACTURING BATCH RECORD REVIEW (BRR) REVEALED THAT THE PRODUCT MET ACCEPTANCE CRITERIA FOR RELEASE, AND REVIEW OF COMPLAINTS AGAINST THE KIT LOT FOR THE REPORTED ISSUE INDICATES THAT THE PRODUCT IS PERFORMING ACCORDING TO THE STATEMENTS CONTAINED IN THE PACKAGE INSERT AND A PRODUCT DEFICIENCY HAS NOT BEEN IDENTIFIED. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD POSSIBLY BE RELATED TO ISSUES INCLUDING THE SPECIFIC PATIENT SAMPLE.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. PLEASE REFERENCED: 1221359-2021-02225.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN TEST PERFORMED ON (B)(6) 2021 ON A TESTED MID-NASAL KITTED SWAB USING TWO DIFFERENT LOTS. THIS MFR. REPORT ADDRESSES LOT 1 OF 2. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THEBINAXNOW COVID-19 ANTIGEN TEST PERFORMED (B)(6) 2021 ON A TESTED MID-NASAL SWAB AND GENERATED POSITIVE RESULTS. ON THE SAME DAY REPEAT TESTING WAS PERFORMED WITH A NEW BINAXNOW CARD AND WITH A NEW SAMPLE AND AGAIN GENERATED NEGATIVE RESULTS. THE CUSTOMER REPORTED PCR CONFIRMATION TESTING WAS PERFORMED (B)(6) 2021 ON AMID-NASAL SWAB AND GENERATED NEGATIVE RESULTS. THE CUSTOMER REPORTED THAT THE PATIENT TOOK A TOTAL OF (4) BINAXNOW COVID-19 ANTIGEN TEST, (3) USING LOT # 153364 AND (1) USING LOT # 154389. THE CUSTOMER STATED THE PATIENT WAS NOT SYMPTOMATIC AND THE PATIENT WAS VACCINATED (PFIZER). THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186341 BINAX NOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 153364

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female