BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAX NOW COVID-19 AG CARD

    MDR report key: 12818767 · Received November 16, 2021

    Report

    Report Number
    1221359-2021-03435
    Event Type
    Malfunction
    Date Received
    November 16, 2021
    Report Date
    February 13, 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
    ND, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. PLEASE SEE UPDATES:B6, G3, G6 AND H2. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATES 56 FALSE NEGATIVES RESULTS WITH THE BINAXNOW¿ COVID-19 ANTIGEN CARD PERFORMED BETWEEN (B)(6) 2021 AND (B)(6) 2021. THIS MFR. REPORT ADDRESSES PATIENT (B)(6). THE CUSTOMER REPORTED (1) FALSE NEGATIVE RESULT WITH THE BINAXNOW¿ COVID-19 ANTIGEN CARD PERFORMED ON (B)(6) 2021, USING OROPHARYNGEAL SWAB SAMPLE. PCR CONFIRMATION TESTING ON OROPHARYNGEAL SAMPLES WITH AMPLITUDE GENERATED POSITIVE RESULTS (CT VALUES = 19.63). THE CUSTOMER REPORTED THAT THE PATIENT WAS SYMPTOMATIC. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED. SINCE THE CUSTOMER CONFIRMED THE PREVIOUSLY REPORTED 7 FALSE NEGATIVE RESULTS ARE INCLUDED IN THE 56 RESULTS MENTIONED AN ADDITIONAL 49 REPORTS WILL BE SUBMITTED TO ADDRESS THIS COMPLAINT. PLEASE ALSO REFERENCE MFR. REPORT #S 1221359-2021-03435, 1221359-2021-02489, 1221359-2021-03769 THRU 1221359-2021- 03774 AND 1221359-2021-03775 THRU 1221359-2021-03822.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE INVESTIGATION CONCLUSION. THE CUSTOMER RETURNED KITS WERE TESTED WITH THE FOLLOWING: 70 LOD AND 4 NEGATIVE CONTROL (BLANK SWAB). 4 CUSTOMER KITS WERE RECEIVED AND SPLIT AS DETAILED BELOW: KIT 1: TESTED 18 LOD AND 1 NEGATIVE CONTROL. KIT 2: TESTED 18 LOD AND 1 NEGATIVE CONTROL. KIT 3: TESTED 17 LOD AND 1 NEGATIVE CONTROL. KIT 4: TESTED 17 LOD AND 1 NEGATIVE CONTROL. ALL TESTING WAS VALID AND PERFORMED AS EXPECTED WITH NO FALSE NEGATIVE OR INVALID RESULTS OBSERVED. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 131522 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 191-000 / LOT 131522 AND TEST BASE PART NUMBER 190-430 / LOT 131522. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 131522 SHOWED THAT THE COMPLAINT RATE IS (B)(4). IN CONCLUSION, THE MANUFACTURING BATCH RECORD REVIEW (BRR) REVEALED THAT THE PRODUCT MET ACCEPTANCE CRITERIA FOR RELEASE, AND REVIEW OF COMPLAINTS AGAINST THE KIT LOT FOR THE REPORTED ISSUE INDICATES THAT THE PRODUCT IS PERFORMING ACCORDING TO THE STATEMENTS CONTAINED IN THE PACKAGE INSERT AND A PRODUCT DEFICIENCY HAS NOT BEEN IDENTIFIED. 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.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE NEGATIVES RESULTS WITH THE BINAXNOW¿ COVID-19 ANTIGEN CARD PERFORMED ON UNKNOWN SAMPLES. THE CUSTOMER REPORTED THAT THEY HAVE SEQUESTERED (B)(4) INDIVIDUAL KITS FOR THE LOT NUMBER 131522 BINAX NOW 195-000 DUE TO THE FALSE NEGATIVES THAT THEY HAVE HAD WITH THE PRODUCT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1722876 BINAX NOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 131522 10811877011290

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown