BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 10CT

    MDR report key: 20387779 · Received October 7, 2024

    Report

    Report Number
    1221359-2024-00636
    Event Type
    Malfunction
    Date Received
    October 7, 2024
    Date of Event
    August 28, 2024
    Report Date
    October 23, 2024
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    00811877011118
    PMA / PMN Number
    EUA210264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3: THE DATE INDICATED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 870972B 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 KIT PART NUMBER 195-170/ LOT 870972B AND DEVICE PART NUMBER 195-430WJR/ LOT 870972. 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 870972 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    B3: THE DATE INDICATED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED.THE REMAINDER OF THE INVESTIGATION IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED PENDING COMPLETION, OR UPON RECEIPT OF NEW INFORMATION.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED MULTIPLE FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON VARIOUS DATES. THIS MFR. REPORT IS THREE (3) OF 4 (FOUR). THE CONSUMER REPORTED AN UNKNOW QUANTITY OF FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED BETWEEN THE DATES (B)(6) 2024 WITH UNKNOWN SAMPLE TYPE. CONFIRMATORY TESTING WAS PERFORMED USING PCR TEST WITH UNKNOW SAMPLE TYPE ON (B)(6) 2024 WHICH GAVE NEGATIVE RESULT. ADDITIONAL TESTING WAS PERFORMED USING FLOW FLEX TEST WITH UNKNOW SAMPLE TYPE ON (B)(6) 2024 WHICH GAVE NEGATIVE RESULT. THE CONSUMER CONFIRMED THAT SHE WAS ASYMPTOMATIC AND NO PATIENT HARM DUE TO THE TEST RESULTS.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED MULTIPLE FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON VARIOUS DATES. THIS MFR. REPORT IS THREE (3) OF 4 (FOUR). THE CONSUMER REPORTED AN UNKNOW QUANTITY OF FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED BETWEEN THE DATES 28AUG2024 AND 20SEP2024 WITH UNKNOWN SAMPLE TYPE. CONFIRMATORY TESTING WAS PERFORMED USING PCR TEST WITH UNKNOW SAMPLE TYPE ON 28AUG2024 WHICH GAVE NEGATIVE RESULT. ADDITIONAL TESTING WAS PERFORMED USING FLOW FLEX TEST WITH UNKNOW SAMPLE TYPE ON 25SEP2024 WHICH GAVE NEGATIVE RESULT. THE CONSUMER CONFIRMED THAT SHE WAS ASYMPTOMATIC AND NO PATIENT HARM DUE TO THE TEST RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224881 BINAXNOW COVID-19 AG SELF TEST 10CT LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 870972B 00811877011118

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female