BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAX NOW COVID-19 AG CARD

    MDR report key: 12334925 · Received August 18, 2021

    Report

    Report Number
    1221359-2021-02316
    Event Type
    Malfunction
    Date Received
    August 18, 2021
    Report Date
    December 18, 2021
    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. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 195-160/ LOT 153476 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 148405. TEST BASE PART NUMBER 190-100 / LOT 153476. 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 153476 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN UNCONFIRMED FALSE POSITIVE RESULT WITH THE BINAXNOW¿ COVID-19 ANTIGEN SELF TEST PERFORMED ON (B)(6) 2021 ON A DIRECT TESTED NASAL KITTED SWAB. REPEAT TESTING WAS NOT PERFORMED AS THE CONSUMER WANTED TO PERFORM THE SECOND TEST AT THEIR PHYSICIANS OFFICE. THE CUSTOMER REPORTED THAT SHE GOT A SOLID PINK CONTROL LINE AND SOLID PINK SAMPLE LINE, BUT SHE'S NOT SURE IF THIS IS ACCURATE AND VALID BECAUSE WHILE ROTATING THE NASAL SWAB FROM THE TOP HOLE, SOME OF THE REAGENT SOLUTION SPILLED OUT OF THE HOLE. THE CONSUMER DIDN'T KNOW IF SHE HAD A COLD BUT SHE WAS WORRIED BECAUSE 7 OR 10 DAYS AGO SHE WAS EXPOSED TO SOMEONE WHO WAS POSITIVE WITH COVID-19 AND THAT IS WHY SHE WAS PERFORMING THE TEST. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1235762 BINAX NOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 153476 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown