BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 16714494 · Received April 11, 2023

    Report

    Report Number
    1221359-2023-00620
    Event Type
    Malfunction
    Date Received
    April 11, 2023
    Date of Event
    April 1, 2023
    Report Date
    April 11, 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

    B3: THE EVENTS DATE IS AN ESTIMATE. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 211651 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 211651 AND DEVICE PART NUMBER 195-430H / LOT 208046. 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 211651 SHOWED THAT THE COMPLAINT RATE IS 0.000975%. ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE E, HOWEVER IT COULD HAVE POSSIBLY BEEN RELATED TO THE SPECIFIC PATIENT SAMPLE. BASED ON THE ABOVE SUMMARY, THE INVESTIGATION IS DEEMED COMPLETE. ABBOTT DIAGNOSTICS SCARBOROUGH WILL CONTINUE TO MONITOR AND TREND FOR THIS REPORTED ISSUE. H3 : DEVICE DISCARDED, SINGLE USE.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED NINE (9) FALSE NEGATIVE RESULTS WITH BINAXNOW COVID-19 AG SELF-TEST ON (B)(6) 2023 ON NASAL SAMPLE. THE CONSUMER RECEIVED NINE (9) NEGATIVE RESULTS WITH BINAXNOW COVID-19 AG SELF-TEST, AND A POSITIVE RESULT AT THE DOCTOR CLINIC. THE CONSUMER HAD MUSCLE ACHES AND HEADACHE AND SORE THROAT. THIS MFR. REPORT ADDRESSES TEST NINE (9) OF NINE (9) TESTS, IN REGARD TO LOT NUMBER (211651) QUANTITY (2). NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380026 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 211651 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female