BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAX NOW COVID-19 AG CARD

    MDR report key: 12568052 · Received October 4, 2021

    Report

    Report Number
    1221359-2021-02901
    Event Type
    Malfunction
    Date Received
    October 4, 2021
    Date of Event
    August 24, 2021
    Report Date
    April 10, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    00811877011408
    PMA / PMN Number
    EUA202537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE INVESTIGATION CONCLUSION AND TO CORRECT THE MFR. REPORT NUMBER FROM 1221359-2021-03822 TO 1221359-2021-02901. PLEASE SEE UPDATES: G3, G6, H2 AND H6. CORRECTION : REMEDIAL REVIEW OF THIS CASE FOUND THAT THE INFORMATION CONTAINED THIS FOLLOW UP REPORT WAS SUBMITTED USING THE INCORRECT MFR. REPORT NUMBER. ADDITIONAL INFORMATION: THE CUSTOMER REPORTED THAT THERE WAS NO ISSUE AS OF NOW AS THE INSTRUMENT WAS REPLACED. INVESTIGATION: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT 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 195-160 / LOT 153364 AND TEST BASE PART NUMBER 195-430H / LOT 148134. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 153364 SHOWED THAT THE COMPLAINT RATE IS 0.002%. 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 SELF-TEST USER PERFORMANCE, INTERPRETATION OF THE RESULT, OR THE SPECIFIC PATIENT SAMPLE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW¿ COVID-19 ANTIGEN SELF TEST ON (B)(6) 2021 ON AN UNKNOWN SAMPLE. THE CUSTOMER REPORTED THAT SHE TOOK THE FIRST BINAXNOW¿ COVID-19 ANTIGEN SELF TEST (B)(6) 2021 AND IT SHOWED A SUPER FAINT PINK CONTROL LINE WITH NO COLOR UNDER SAMPLE LINE. THIS IS CLASSIFIED AS A NEGATIVE RESULT. THE CUSTOMER REPORTED THAT SHE TOOK A PCR CONFIRMATION TEST AND OBTAINED A POSITIVE RESULT. THE CUSTOMER REPORTED THAT HER HUSBAND TOOK THE SECOND TEST AND OBTAINED NEGATIVE RESULTS AND NO ISSUE WITH HIS TEST. THE CUSTOMER REPORTED HER HUSBAND WAS OK NOW AND HE DOESN'T HAVE COVID-19 SIGNS AND SYMPTOM, HE COUGH SOMETIME BUT HE WAS COMPLETELY FINE. THE CUSTOMER REPORTED THAT SHE PURCHASED THE TEST AT (B)(6) ONLINE FOUR DAYS AGO (B)(6) 2021. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1469233 BINAX NOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 153364 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Female