BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 18324874 · Received December 14, 2023

    Report

    Report Number
    1221359-2023-01750
    Event Type
    Malfunction
    Date Received
    December 14, 2023
    Date of Event
    November 28, 2023
    Report Date
    February 8, 2024
    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

    FDA UDI: (B)(4) THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    FDA UDI (B)(4) TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 227417 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 227417 AND DEVICE PART NUMBER 195-430H/ LOT 223559. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 227417 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, HOWEVER IT COULD HAVE POSSIBLY BEEN RELATED TO ISSUES INCLUDING THE SELF-TEST USER PERFORMANCE, INTERPRETATION OF THE RESULT, OR THE SPECIFIC PATIENT SAMPLE.H2 - DEVICE EVALUATION / ADDITIONAL INFORMATION H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    FDA UDI (B)(6) TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 227417 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 227417 AND DEVICE PART NUMBER 195-430H/ LOT 223559. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 227417 SHOWED THAT THE COMPLAINT RATE IS (B)(4)%. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, HOWEVER IT COULD HAVE POSSIBLY BEEN RELATED TO ISSUES INCLUDING THE SELF-TEST USER PERFORMANCE, INTERPRETATION OF THE RESULT, OR THE SPECIFIC PATIENT SAMPLE. H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED THREE FALSE NEGATIVE RESULTS WITH A BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON VARIOUS DATES ON A NASAL SAMPLE. THIS MANUFACTURER¿S REPORT ADDRESSES TEST THREE (3) OF THREE (3). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2023. CONSUMER PERFORMED A FLOWFLEX ANTIGEN SELF-TEST ON AN UNKNOWN DATE AND GENERATED A POSITIVE RESULT. THE CONSUMER WAS SYMPTOMATIC WITH CHILLS, FEELING HOT, NAUSEA, AND AN ACHING HEAD. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED

    Description of Event or Problem · 0

    THE CONSUMER REPORTED THREE FALSE NEGATIVE RESULTS WITH A BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON VARIOUS DATES ON A NASAL SAMPLE. THIS MANUFACTURER¿S REPORT ADDRESSES TEST THREE (3) OF THREE (3). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6)2023. CONSUMER PERFORMED A FLOWFLEX ANTIGEN SELF-TEST ON AN UNKNOWN DATE AND GENERATED A POSITIVE RESULT. THE CONSUMER WAS SYMPTOMATIC WITH CHILLS, FEELING HOT, NAUSEA, AND AN ACHING HEAD. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED

    Description of Event or Problem · 0

    THE CONSUMER REPORTED THREE FALSE NEGATIVE RESULTS WITH A BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON VARIOUS DATES ON A NASAL SAMPLE. THIS MANUFACTURER¿S REPORT ADDRESSES TEST THREE (3) OF THREE (3). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON 28NOV2023. CONSUMER PERFORMED A FLOWFLEX ANTIGEN SELF-TEST ON AN UNKNOWN DATE AND GENERATED A POSITIVE RESULT. THE CONSUMER WAS SYMPTOMATIC WITH CHILLS, FEELING HOT, NAUSEA, AND AN ACHING HEAD. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1769967 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 227417 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Female