BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    MDR report key: 13983833 · Received April 1, 2022

    Report

    Report Number
    1221359-2022-02057
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    Date of Event
    March 14, 2022
    Report Date
    April 1, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    00811877011408
    PMA / PMN Number
    EUA210264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 185000 WITH THE ABBOTT DIAGNOSTICS (B)(4) LIMIT OF DETECTION (LOD) POSITIVE QUALITY CONTROL X3 DEVICES AND NEGATIVE (BLANK) SWABS X3 DEVICES. ALL TESTS WERE VALID AND PERFORMED AS EXPECTED WITH NO FALSE NEGATIVE RESULTS REPLICATED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR KIT PART NUMBER 195-160/195-260 / LOT 185000 AND DEVICE PART NUMBER 195-430H/ LOT 181526. QUALITY CONTROL RELEASE TESTING MET SPECIFICATIONS AND THERE WERE NO FALSE NEGATIVE RESULTS OBSERVED. THE CURRENT OVERALL INCIDENT RATE FOR FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) FOR THIS SPECIFIC LOT BASED ON THE TOTAL QUANTITY OF DEVICES MANUFACTURED FOR DISTRIBUTION IS (B)(4). BASED ON THE EVIDENCE AVAILABLE, IT INDICATES THAT THIS DEVICE LOT IS PERFORMING WITHIN THE STATEMENTS MADE WITHIN THE PACKAGE INSERT STATEMENTS. IN CONCLUSION, THE RETENTION TESTING YIELDED EXPECTED RESULTS WHEN TESTING INTERNAL QC SAMPLES, 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 (B)(4) WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD POSSIBLY BE RELATED TO ISSUES INCLUDING THE SELF-TEST USER PERFORMANCE, INTERPRETATION OF THE RESULT, OR THE SPECIFIC PATIENT SAMPLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST PERFORMED ON (B)(6) 2022. CONFIRMATION TESTING WAS PERFORMED WITH THE ACON LABORATORIES FLOW FLEX TEST AND GENERATED A POSITIVE RESULT. THE CONSUMER STATED THAT SHE WAS ASYMPTOMATIC. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2492426 BINAXNOW COVID-19 ANTIGEN SELF-TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 185000 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown