BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    MDR report key: 12595590 · Received October 7, 2021

    Report

    Report Number
    1221359-2021-03116
    Event Type
    Malfunction
    Date Received
    October 7, 2021
    Date of Event
    July 12, 2021
    Report Date
    December 1, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCABOROUGH
    Product Code
    QKP
    UDI-DI
    00811877011408
    PMA / PMN Number
    EUA210264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE CORRECTED DATA AND ADDITIONAL INFORMATION. PLEASE SEE UPDATES FIELDS: D1, D2, D3, D4, G1, G3, G4 AND H4.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 153364 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 153364 AND DEVICE PART NUMBER 195-430H / LOT 148134. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS XXXXXXXX PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 153364 SHOWED THAT THE COMPLAINT RATE IS (B)(4). IN ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE

    Additional Manufacturer Narrative · 0

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 0

    THE CALLER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 PERFORMED ON (B)(6) 2021 ON A DIRECT TESTED NASAL KITTED SWAB. REPEAT TESTING WAS PERFORMED GENERATED NEGATIVE RESULTS. CONFIRMATION TESTING WITH PCR GENERATED NEGATIVE RESULTS. THE CUSTOMER STATES THE USER WAS ASYMPTOMATIC. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1485301 BINAXNOW COVID-19 ANTIGEN SELF-TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ABBOTT DIAGNOSTICS SCABOROUGH 195000 154389 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female