BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 16004817 · Received December 19, 2022

    Report

    Report Number
    1221359-2022-10357
    Event Type
    Malfunction
    Date Received
    December 19, 2022
    Date of Event
    December 14, 2022
    Report Date
    February 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

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 194723 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 194723, TEST BASE PART NUMBER 195-430H/ 190123. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 194723 SHOWED THAT THE COMPLAINT RATE IS 0.000327%. 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 OR THE SPECIFIC PATIENT SAMPLE. BASED ON THE ABOVE SUMMARY, THE INVESTIGATION IS DEEMED COMPLETE. THE PRODUCT WILL CONTINUE TO BE MONITORED AND TRACKED. H3 OTHER TEXT : DEVICE DISCARDED, SINGLE USE.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. DEVICE DISCARDED, SINGLE USE.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE POSITIVE WITH BINAXNOW COVID-19 AG SELF-TEST ON 14DEC2022. PER CONSUMER, THEIR DAUGHTER PERFORMED TWO TESTS WITH BINAXNOW COVID-19 AG SELF-TEST ON (B)(6) 2022; THE FIRST TEST WAS POSITIVE, AND THE SECOND TEST WAS NEGATIVE. ALSO, THE DAUGHTER PERFORMED TWO TESTS WITH UNKNOWN BRAND, AND SHE RECEIVED NEGATIVE RESULTS ON THEM. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE POSITIVE WITH BINAXNOW COVID-19 AG SELF-TEST ON (B)(6) 2022. PER CONSUMER, THEIR DAUGHTER PERFORMED TWO TESTS WITH BINAXNOW COVID-19 AG SELF-TEST ON (B)(6) 2022; THE FIRST TEST WAS POSITIVE, AND THE SECOND TEST WAS NEGATIVE. ALSO, THE DAUGHTER PERFORMED TWO TESTS WITH UNKNOWN BRAND, AND SHE RECEIVED NEGATIVE RESULTS ON THEM. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2701379 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 194723 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Female