BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 16179464 · Received January 16, 2023

    Report

    Report Number
    1221359-2023-00107
    Event Type
    Malfunction
    Date Received
    January 16, 2023
    Date of Event
    January 14, 2023
    Report Date
    March 15, 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. DEVICE DISCARDED, SINGLE USE.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 211595 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 NUMBER195-160 / LOT 211595 AND DEVICE PART NUMBER 195-430H / LOT 207161. A REVIEW OF THE COMPLAINTS REPORTED FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 211595 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD POSSIBLY BE RELATED TO ISSUES INCLUDING THE SELF-TEST USER PERFORMANCE, INTERPRETATION OF THE RESULT, OR 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 OTHER TEXT : DEVICE DISCARDED, SINGLE USE.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED AN UNCONFIRMED FALSE NEGATIVE RESULT WITH BINAXNOW COVID-19 AG SELF-TEST ON (B)(6) 2023. THE CONSUMER RECEIVED A POSITIVE RESULT ON UNKNOWN BRAND TEST ON (B)(6) 2023, AND A NEGATIVE RESULT ON BINAXNOW COVID-19 AG SELF-TEST ON (B)(6) 2023.A CONFIRMATORY TEST WAS NOT PERFORMED. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED AN UNCONFIRMED FALSE NEGATIVE RESULT WITH BINAXNOW COVID-19 AG SELF-TEST ON (B)(6) 2023. THE CONSUMER RECEIVED A POSITIVE RESULT ON UNKNOWN BRAND TEST ON (B)(6) 2023, AND A NEGATIVE RESULT ON BINAXNOW COVID-19 AG SELF-TEST ON (B)(6) 2023. A CONFIRMATORY TEST WAS NOT PERFORMED. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1656360 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 211595 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male