BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG CARD

    MDR report key: 13108616 · Received December 29, 2021

    Report

    Report Number
    1221359-2021-03802
    Event Type
    Malfunction
    Date Received
    December 29, 2021
    Report Date
    December 9, 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 THE INVESTIGATION CONCLUSION. PLEASE SEE UPDATES: G3, G6, H2 AND H6. 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

    THIS REPORT IS BEING SUBMITTED TO CORRECT THE FOLLOWING FIELDS OF THE INTIAL REPORT.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED 56 FALSE NEGATIVES RESULTS WITH THE BINAXNOW¿ COVID-19 ANTIGEN CARD PERFORMED BETWEEN (B)(6) 2021. THIS MFR. REPORT ADDRESSES PATIENT 35OF 56. 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 = 20.5). THE CUSTOMER REPORTED THAT THE PATIENT WAS SYMPTOMATIC. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED. IN ADDITION, THE CUSTOMER HAS REPORTED THAT THEY HAVE SEQUESTERED (B)(4) INDIVIDUAL KITS OF THE BINAXNOW¿ COVID-19 ANTIGEN CARD TEST FOR THE MENTIONED LOT NUMBER DUE TO THE FALSE NEGATIVES THE CUSTOMER HAS RECEIVED WITH THE PRODUCT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2001923 BINAXNOW COVID-19 AG CARD CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 131522 10811877011290

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown