BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAX NOW COVID-19 SELF TEST

    MDR report key: 12222531 · Received July 24, 2021

    Report

    Report Number
    1221359-2021-02112
    Event Type
    Malfunction
    Date Received
    July 24, 2021
    Date of Event
    June 24, 2021
    Report Date
    December 14, 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
    003

    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 153658 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 195-230WL & 195-430WL / LOT 149501. TEST BASE PART NUMBER 195-160 / LOT 153658. 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 153658 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. NOTE THAT THE CUSTOMER MAY NOT HAVE TURNED THE SWAB A TOTAL OF THREE TIMES AFTER INSERTING IT INTO THE TEST CARD AS INSTRUCTED IN THE PACKAGE INSERT. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD POSSIBLY BE RELATED TO INCORRECT TEST PROCEDURE OR THE SPECIFIC PATIENT SAMPLES.

    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 CONSMER'S SPOUSE REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON (B)(6) 2021 ON A TESTED NASAL KITTED SWAB. THE CONSUMER'S SPOUSE REPORTED HIS WIFE TOOK THE FIRST BINAXNOW COVID-19 AG SELF TEST ON (B)(6) 2021 AND OBTAINED A NEGATIVE RESULT. ON (B)(6) 2021 REPEAT TESTING WAS PERFORMED WITH BINAXNOW COVID-19 AG SELF TEST AND AGAIN NEGATIVE RESULTS WERE OBTAINED. PCR CONFIRMATION TESTING WAS PERFORMED AT A HOSPITAL AND GENERATED POSITIVE RESULTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119563 BINAX NOW COVID-19 SELF TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 153658 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Female