BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAX NOW COVID-19 AG CARD

    MDR report key: 12377586 · Received August 27, 2021

    Report

    Report Number
    1221359-2021-02438
    Event Type
    Malfunction
    Date Received
    August 27, 2021
    Date of Event
    July 29, 2021
    Report Date
    December 5, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    00811877011408
    PMA / PMN Number
    EUA210264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT THE FOLLOWING FIELDS. C IS UPDATED SO THAT G4 WILL NO LONGER HAVE "COMBINATION PRODUCT" CHECKED. UPDATED FIELDS: C, G3, G6, H2.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT THE FOLLOWING FIELDS OF THE INTIAL REPORT.

    Additional Manufacturer Narrative · 0

    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 POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 153364 SHOWED THAT THE COMPLAINT RATE IS (B)(4). IN CONCLUSION, 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, 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 POSITIVE RESULT WITH THE BINAXNOW¿ COVID-19 ANTIGEN SELF TEST PERFORMED ON (B)(6) 2021 ON A DIRECT TESTED NASAL KITTED SWAB GENERATED POSITIVE RESULTS. ON (B)(6) 2021 REPEAT TESTING WAS PERFORMED WITH THE BINAXNOW¿ COVID-19 ANTIGEN SELF TEST PERFORMED ON (B)(6) 2021 ON A DIRECT TESTED NASAL KITTED SWAB ALSO GENERATED POSITIVE RESULTS. ON (B)(6) 2021, HE DID A RT-PCR TEST AT (B)(6) AND GENERATED NEGATIVE RESULTS. THE CONSUMER STATED HE WAS SYMPTOMATIC. THE CONSUMER REPORTED HE WAS SELF TRIAGING AND TAKING THE FOLLOWING MEDICATIONS IN RESPONSE TO SYMPTOMS THAT SORT OF LOOKED LIKE A COVID INFECTION, MEDICATION: VIT-D 5000IU, MAGNESIUM 250 MG, ZINC 50 MG, CALCIUM 500MG, IVERMECTIN 15MG . NO TREATMENT WAS PROVIDED AND NO MEDICAL FOLLOW UP WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1276512 BINAX NOW COVID-19 AG CARD CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 153364 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown