BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 16247480 · Received January 26, 2023

    Report

    Report Number
    1221359-2023-00157
    Event Type
    Malfunction
    Date Received
    January 26, 2023
    Date of Event
    January 24, 2023
    Report Date
    April 10, 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 INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 225141 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 225141 AND DEVICE PART NUMBER 195-430WJR / LOT 222477. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 225141 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. D4: EXPIRATION DATE . H3 OTHER TEXT : DEVICE DISCARDED, SINGLE USE.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED TWO UNCONFIRMED FALSE NEGATIVE RESULTS WITH BINAXNOW COVID-19 AG SELF-TEST ON 24JAN2023. THE CONSUMER PERFORMED TWO TESTS ON BINAXNOW COVID-19 AG SELF-TEST ON 24JAN2023 AND RECEIVED NEGATIVE RESULTS. THE CONSUMER PERFORMED ANOTHER TEST (UNKNOWN BRAND) ON 23JAN2023, AND SHE RECEIVED A POSITIVE RESULT. NO CONFIRMATORY TEST WAS PERFORMED. THE CONSUMER WAS ASYMPTOMATIC. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF TWO (2) TESTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED TWO UNCONFIRMED FALSE NEGATIVE RESULTS WITH BINAXNOW COVID-19 AG SELF-TEST ON (B)(6) 2023. THE CONSUMER PERFORMED TWO TESTS ON BINAXNOW COVID-19 AG SELF-TEST ON (B)(6) 2023 AND RECEIVED NEGATIVE RESULTS. THE CONSUMER PERFORMED ANOTHER TEST (UNKNOWN BRAND) ON (B)(6) 2023, AND SHE RECEIVED A POSITIVE RESULT. NO CONFIRMATORY TEST WAS PERFORMED. THE CONSUMER WAS ASYMPTOMATIC. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF TWO (2) TESTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786323 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 225141 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female