BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 18145146 · Received November 15, 2023

    Report

    Report Number
    1221359-2023-01664
    Event Type
    Malfunction
    Date Received
    November 15, 2023
    Date of Event
    October 31, 2023
    Report Date
    December 5, 2023
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER PROVIDED THE INFORMATION FOR TWO LOT NUMBERS BUT DID NOT CLARIFY WHICH LOT GENERATED WHICH RESULT. D4: LOT: 225711, EXP DATE: 20AUG2024, UDI: (B)(4). LOT: 202867 EXP DATE: 13FEB2024, UDI: (B)(4). INVESTIGATION RESULTS FOR LOT 225711: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 225711 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: 225711, TEST BASE PART NUMBER 195-430WJR/ LOT: 223210. 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 225711 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD HAVE POSSIBLY BEEN RELATED TO THE SPECIFIC PATIENT SAMPLE. INVESTIGATION RESULTS FOR LOT 202867: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 202867 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: 202867, TEST BASE PART NUMBER 195-430H/ LOT: 197654. 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 202867 SHOWED THAT THE COMPLAINT RATE IS (B)(4).. ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD HAVE POSSIBLY BEEN RELATED TO THE SPECIFIC PATIENT SAMPLE.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER PROVIDED THE INFORMATION FOR TWO LOT NUMBERS BUT DID NOT CLARIFY WHICH LOT GENERATED WHICH RESULT. D4: LOT: 225711, EXP DATE: 20AUG2024, UDI: (B)(4). LOT: 202867 EXP DATE: 13FEB2024, UDI: (B)(4). THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION OR UPON RECEIPT OF NEW INFORMATION. H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED TWO (2) FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON 31OCT2023 THIS MFR. REPORT ADDRESSES TEST TWO (2) OF TWO (2). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON 31OCT2023 ON A NASAL KITTED SWAB. INITIAL TESTING WAS PERFORMED TWICE WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST ON 31OCT2023 AND YIELDED A POSITIVE AND NEGATIVE RESULT. ADDITIONAL TESTING WAS PERFORMED ON 31OCT2023 THREE (3) TIMES: AN ¿AT HOME PCR¿ TEST, A FLOWFLEX RAPID ANTIGEN TEST, AND A QUICKVIEW RAPID ANTIGEN TEST ALL GENERATING NEGATIVE RESULTS. THE CONSUMER CONFIRMED THERE WAS NO HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CONSUMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN TREATMENT.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED TWO (2) FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON 31OCT2023 THIS MFR. REPORT ADDRESSES TEST TWO (2) OF TWO (2). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON 31OCT2023 ON A NASAL KITTED SWAB. INITIAL TESTING WAS PERFORMED TWICE WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST ON 31OCT2023 AND YIELDED A POSITIVE AND NEGATIVE RESULT. ADDITIONAL TESTING WAS PERFORMED ON 31OCT2023 THREE (3) TIMES: AN ¿AT HOME PCR¿ TEST, A FLOWFLEX RAPID ANTIGEN TEST, AND A QUICKVIEW RAPID ANTIGEN TEST ALL GENERATING NEGATIVE RESULTS. THE CONSUMER CONFIRMED THERE WAS NO HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CONSUMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2079505 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. UNKNOWN 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Male