BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    MDR report key: 14251643 · Received April 29, 2022

    Report

    Report Number
    1221359-2022-02241
    Event Type
    Malfunction
    Date Received
    April 29, 2022
    Date of Event
    January 13, 2022
    Report Date
    May 24, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INFORMATION TO ENABLE FURTHER INVESTIGATION, SUCH AS THE KIT'S LOT NUMBER, WAS NOT PROVIDED AND AN INVESTIGATION WAS NOT ABLE TO BE PERFORMED. NOTWITHSTANDING, COMPLAINTS AGAINST THESE TREND CODES ARE MONITORED TO IDENTIFY AND TRACK ANY OUT-OF-TREND/UNEXPECTED PERFORMANCE AS THE LOT AND PRODUCT FAMILY LEVEL. IN CONCLUSION, ABBOTT DIAGNOSTICS (B)(4) WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUES AS NO INFORMATION WAS PROVIDED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 173318 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: 173318, TEST BASE PART NUMBER 195-430WL / LOT: 170717. 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 173318 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 BE RELATED TO ISSUES INCLUDING THE SELF-TEST USER PERFORMANCE, INTERPRETATION OF THE RESULT, OR THE SPECIFIC PATIENT SAMPLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2022 ON A NASAL SAMPLE. CONFIRMATION TESTING VIA AN UNKNOWN PCR PLATFORM ON (B)(6) 2022 GENERATED POSITIVE RESULTS. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212836 BINAXNOW COVID-19 ANTIGEN SELF-TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 173318 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Unknown