BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG CARD

    MDR report key: 15566356 · Received October 7, 2022

    Report

    Report Number
    1221359-2022-04609
    Event Type
    Malfunction
    Date Received
    October 7, 2022
    Date of Event
    June 7, 2022
    Report Date
    October 10, 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

    ADDITIONAL INFORMATION: PATIENT IDENTIFIER: (B)(6). LOT NUMBER REPORTED BY THE CUSTOMER, 170182, WAS FOUND TO BE INVALID FOR THIS CATALOG NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION FROM CUSTOMER BUT NO RESPONSE HAS BEEN RECEIVED TO-DATE. INVESTIGATION SUMMARY: THE REQUIRED INTAKE 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, A REVIEW OF COMPLAINTS' TREND REVEALS THAT ALL LOTS WITHIN EXPIRY DATING ARE PERFORMING ACCORDING TO THE STATEMENTS MADE IN THE PACKAGE INSERT. 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. REFERENCE RELATED MFR. REPORT NUMBERS: 1221359-2022-04568 THROUGH 1221359-2022-04758.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, 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 170722 AND DEVICE PART NUMBER 195-430H/ LOT 167145. 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 SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD POSSIBLY BE RELATED TO THE SPECIFIC PATIENT SAMPLES.

    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 FORTY-TWO (42) OF ONE HUNDRED NINETY-ONE (191). 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 SYMPTOMATIC 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).

    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 JUN2022 PERFORMED ON MULTIPLE PATIENTS. THIS MFR. REPORT ADDRESSES RESULT FORTY (40) 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 07JUN2022. 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 SYMPTOMATIC 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
    271963 BINAXNOW COVID-19 AG CARD CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 170179 10811877011290

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male