BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    MDR report key: 15380495 · Received September 8, 2022

    Report

    Report Number
    1221359-2022-02485
    Event Type
    Malfunction
    Date Received
    September 8, 2022
    Date of Event
    August 21, 2022
    Report Date
    September 8, 2022
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 210917 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 210917, TEST BASE PART NUMBER 195-430WJR / LOT 207146. 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 210917 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS (B)(4), 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. REFERENCE MFR. REPORTS: 1221359-2022-02485 AND 1221359-2022-02486.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TWO FALSE NEGATIVE RESULTS WITH BINAXNOW COVID-19 ON (B)(6)2022 ON A SWAB SAMPLE(NASAL).THE CUSTOMER FELT WITH SYMPTOMS ON (B)(6)2022 . THE CUSTOMER RECEIVED A NEGATIVE RESULT ON 16AUG2022, AND THE CUSTOMER RETESTED ON (B)(6)2022 ,AND RECEIVED A NEGATIVE RESULT. A TEST WAS DONE AT A LAB AND CAME BACK POSITIVE ON (B)(6)2022. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF TWO (2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284012 BINAXNOW COVID-19 ANTIGEN SELF-TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC 210917 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown