BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    MDR report key: 12922334 · Received December 3, 2021

    Report

    Report Number
    1221359-2021-03627
    Event Type
    Malfunction
    Date Received
    December 3, 2021
    Report Date
    December 12, 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 SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT THE PREVIOUSLY REPORTED EVENT. CORRECTION TO PREVIOUS REPORTED DETAILS ARE AS FOLLOWS: THE CUSTOMER REPORTED TAKING " THREE PCR TESTS ALL NEGATIVE. TWO WERE THROUGH MY HOSPITAL EMPLOYER AND ONE WAS THROUGH CVS."

    Additional Manufacturer Narrative · 0

    THE SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT THE PREVIOUSLY REPORTED EVENT AND PROVIDE ADDITIONAL INFORMATION. PLEASE SEE UPDATES: D1, D2, D3, D5, D9, G1, G3, G6, H2 AND H8. CORRECTED DATA: D1, D2, D5 & H8 ADDITIONAL INFORMATION: D3, D9 & G1.

    Additional Manufacturer Narrative · 0

    AN ADDITIONAL LOT WAS USED DURING TESTING: LOT NUMBER - 155962C UDI - (B)(4). TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 158058 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 195-160/195-260 / LOT 158058 AND TEST BASE PART NUMBER 195-430H / LOT 154189. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 155962C 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 195-160/195-260 / LOT 155962C AND TEST BASE PART NUMBER 195-430H / LOT 152945. 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 158058 SHOWED THAT THE COMPLAINT RATE IS (B)(4). A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 155962C 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, INTERPRETATION OF THE RESULT, OR THE SPECIFIC PATIENT SAMPLE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED MULTIPLE FALSE POSITIVE RESULTS WITH THE BINAXNOW¿ COVID-19 ANTIGEN SELF TEST PERFORMED (B)(6) 2021 ON A DIRECT TESTED NASAL SWAB GENERATED A NEGATIVE RESULT. REPEAT TEST WAS PERFORMED ON THE SAME DAY AND NEGATIVE RESULTS WERE RECEIVED. THIRD POSITIVE WAS (B)(6) 2021 AT 12:48 AM AND FOURTH POSITIVE WAS (B)(6) 2021 AT 6:12 PM. SYMPTOMS STARTED THE DAY OF ON (B)(6). RUNNY NOSE, SNEEZING, HEADACHE. RAPID ANTIGEN BINAXNOW RAPID HOME TEST. THE CONSUMER HAD TWO PCR TESTS THROUGH WORK THAT BOTH CAME BACK NEGATIVE. THE CONSUMER IS ON VITAMINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1826903 BINAXNOW COVID-19 ANTIGEN SELF-TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 158058 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female