BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 16395834 · Received February 17, 2023

    Report

    Report Number
    1221359-2023-00353
    Event Type
    Malfunction
    Date Received
    February 17, 2023
    Date of Event
    January 27, 2023
    Report Date
    April 20, 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

    INVESTIGATION CONCLUSION: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 221473 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 221473, TEST BASE PART NUMBER 195-430WJR / LOT 219516. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION OR UPON RECEIPT OF NEW INFORMATION.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON 27JAN2023 ON A NASAL SAMPLE. AN ADDITIONAL TEST USING THE SAME LOT OF THE BINAXNOW COVID-19 ANTIGEN SELF-TEST WAS PERFORMED FOURTEEN (14) HOURS LATER AND GENERATED POSITIVE RESULTS. CONFIRMATION PCR TESTING (UNKNOWN PLATFORM) WAS PERFORMED ON AN UNKNOWN DATE AND GENERATED POSITIVE RESULTS. THE CONSUMER WAS REPORTED TO BE SYMPTOMATIC (FEVER, COUGH AND HEADACHE). THE CONSUMER CONFIRMED THERE WAS NO HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CONSUMER CONFIRMED THERE WAS NO DELAY OR IMPACT TO TREATMENT.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2023 ON A NASAL SAMPLE. AN ADDITIONAL TEST USING THE SAME LOT OF THE BINAXNOW COVID-19 ANTIGEN SELF-TEST WAS PERFORMED FOURTEEN (14) HOURS LATER AND GENERATED POSITIVE RESULTS. CONFIRMATION PCR TESTING (UNKNOWN PLATFORM) WAS PERFORMED ON AN UNKNOWN DATE AND GENERATED POSITIVE RESULTS. THE CONSUMER WAS REPORTED TO BE SYMPTOMATIC (FEVER, COUGH AND HEADACHE). THE CONSUMER CONFIRMED THERE WAS NO HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CONSUMER CONFIRMED THERE WAS NO DELAY OR IMPACT TO TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110252 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 221473 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female