BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 15704539 · Received October 31, 2022

    Report

    Report Number
    1221359-2022-10040
    Event Type
    Malfunction
    Date Received
    October 31, 2022
    Date of Event
    October 4, 2022
    Report Date
    January 19, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    00811877011408
    PMA / PMN Number
    EUA210264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. DEVICE DISCARDED, SINGLE USE DEVICE.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 208757 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 208757, TEST BASE PART NUMBER 195-430H / LOT 202949. 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 208757 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. HOWEVER, A POSSIBLE ASSIGNABLE ROOT CAUSE IS SAMPLE INTERFERENCE OR CROSS CONTAMINATION.H6 UPDATED H3 OTHER TEXT : DEVICE DISCARDED, SINGLE USE DEVICE.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF-TEST FOR A PATIENT PERFORMED ON (B)(6) 2022 (SAMPLE TYPE UNKNOWN). PCR CONFIRMATION TESTING (X2) ON (B)(6) 2022 AND (B)(6) 2022 (PLATFORM: UNKNOWN) GENERATED NEGATIVE RESULTS (CT VALUES NOT PROVIDED). THE CONSUMER WAS NOT SYMPTOMATIC. HOWEVER, SHE HAD HEADACHE. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF-TEST FOR A PATIENT PERFORMED ON (B)(6) 2022 (SAMPLE TYPE UNKNOWN). PCR CONFIRMATION TESTING (X2) ON (B)(6) 2022 AND (B)(6) 2022 (PLATFORM: UNKNOWN) GENERATED NEGATIVE RESULTS (CT VALUES NOT PROVIDED). THE CONSUMER WAS NOT SYMPTOMATIC. HOWEVER, SHE HAD HEADACHE. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639343 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 208757 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female