BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG CARD

    MDR report key: 15567146 · Received October 7, 2022

    Report

    Report Number
    1221359-2022-04573
    Event Type
    Malfunction
    Date Received
    October 7, 2022
    Date of Event
    June 21, 2022
    Report Date
    October 7, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    10811877011290
    PMA / PMN Number
    EUA202537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT IDENTIFIER: (B)(6). INVESTIGATION SUMMARY: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 170179 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 KIT PART NUMBER 195-000 / LOT 170179 AND DEVICE PART NUMBER 195-430H / LOT 168292. 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 170179 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS (B)(4) WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD POSSIBLY BE RELATED TO THE SPECIFIC PATIENT SAMPLES. REFERENCE RELATED MFR. REPORT NUMBERS: 1221359-2022-04568 THROUGH 1221359-2022-04758.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED ONE HUNDRED NINETY-ONE (191) FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 AG CARD OCCURRING IN THE MONTH OF (B)(6) 2022 PERFORMED ON MULTIPLE PATIENTS. THIS MFR. REPORT ADDRESSES RESULT SIX (6) OF ONE HUNDRED NINETY-ONE (191) AND LOT NUMBER 170179 (QUANTITY 42). THE PATIENT TESTED NEGATIVE WITH THE BINAXNOW COVID-19 AG CARD ON A NASAL SWAB SAMPLE ON (B)(6) 2022. CONFIRMATION TESTING WAS PERFORMED WITHIN 48 HOURS MOLECULAR TESTING (PCR OR LAMP) USING A SAMPLE OBTAINED AT THE SAME SITE ON THE SAME DAY AND GENERATED POSITIVE RESULTS. THE PATIENT WAS REPORTED TO HAVE BEEN ASYMPTOMATIC AND NOT KNOWN TO BE COVID-19 POSITIVE AT THE TIME OF TESTING. 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. PER THE CUSTOMER NO ADDITIONAL INFORMATION WILL BE PROVIDED ON THE FALSE NEGATIVE RESULTS OR INDIVIDUALS TESTED. PER THE CUSTOMER, ROUTINE TESTING WAS BEING PERFORMED AT COMMUNITY ORGANIZATIONS (NON K-12 SCHOOLS, NON LONG TERM CARE FACILITIES) AND THE AG CARDS HAVE BEEN FUNCTIONING AS EXPECTED. THE CUSTOMER DID NOT ALLEGE A MALFUNCTION OF THE DEVICE AND CONFIRMED THIS IS ROUTINE REPORTING PER THE BINAXNOW COVID-19 AG CARD INSTRUCTIONS FOR USE (IFU).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236368 BINAXNOW COVID-19 AG CARD CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 170179 10811877011290

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male