BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 15758903 · Received November 9, 2022

    Report

    Report Number
    1221359-2022-10078
    Event Type
    Malfunction
    Date Received
    November 9, 2022
    Date of Event
    October 28, 2022
    Report Date
    January 26, 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 211256 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 211256, TEST BASE PART NUMBER 195-430H / LOT 207584. 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 211256 SHOWED THAT THE COMPLAINT RATE IS (B)(4). A PRODUCT DEFICIENCY HAS NOT BEEN IDENTIFIED. BASED ON THE ABOVE SUMMARY, THE INVESTIGATION IS DEEMED CLOSED.THE PRODUCT WILL CONTINUE TO BE MONITORED AND TRACKED. H3 OTHER TEXT: DEVICE DISCARDED, SINGLE USE.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH BINAXNOW COVID-19 AG SELF-TEST ON (B)(6) 2022, ON NASAL SWAB. THE CONSUMER RECEIVED A POSITIVE RESULT WITH UNKNOWN BRAND ON (B)(6) 2022, AND A NEGATIVE RESULT WITH BINAXNOW COVID-19 AG SELF-TEST ON (B)(6) 2022.THE CONSUMER STATED THAT SHE HAD A FEVER ON (B)(6) 2022 AND TOOK VACCINE LAST WEEK. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH BINAXNOW COVID-19 AG SELF-TEST ON (B)(6) 2022, ON NASAL SWAB. THE CONSUMER RECEIVED A POSITIVE RESULT WITH UNKNOWN BRAND ON (B)(6) 2022, AND A NEGATIVE RESULT WITH BINAXNOW COVID-19 AG SELF-TEST ON (B)(6) 2022.THE CONSUMER STATED THAT SHE HAD A FEVER ON (B)(6) 2022 AND TOOK VACCINE LAST WEEK. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2262582 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 211256 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Female