BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 18097029 · Received November 8, 2023

    Report

    Report Number
    1221359-2023-01646
    Event Type
    Malfunction
    Date Received
    November 8, 2023
    Date of Event
    October 3, 2023
    Report Date
    November 21, 2023
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI (B)(6) B3: THE DATE PROVIDED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED. THE QUANTITY OF TESTS USED AND TEST DATES WERE NOT SPECIFIED FOR CONSUMERS TWO (2) AND THREE (3). TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 221038 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 KIT PART NUMBER 195-160 / LOT 221038 AND DEVICE PART NUMBER 195-430H / LOT 217299. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. THE CURRENT OVERALL INCIDENT RATE FOR FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) FOR LOT 221038 BASED ON THE TOTAL QUANTITY OF DEVICES DISTRIBUTED IS (B)(4). IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH 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. H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED

    Additional Manufacturer Narrative · 0

    D4: UDI (B)(4). B3: THE DATE PROVIDED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED. THE QUANTITY OF TESTS USED AND TEST DATES WERE NOT SPECIFIED FOR CONSUMERS TWO (2) AND THREE (3). THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED EIGHT (8) FALSE NEGATIVE RESULTS AMONG THREE (3) CONSUMERS WITH THE BINAXNOW COVID-19 SELF-TEST PERFORMED ON VARIOUS DATES. THIS MFR. REPORT ADDRESSES TEST EIGHT (8) OF EIGHT (8); CONSUMER (TWO) 2 OR THREE (3) OF THREE (3). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 SELF-TEST PERFORMED ON BETWEEN (B)(6)2023 AND (B)(6)2023 ON A NASAL SWAB. ADDITIONAL TESTING WAS PERFORMED WITH A QUICKVIEW ANTIGEN TEST GENERATING A POSITIVE RESULT ON AN UNKNOWN DATE. THE CONSUMER CONFIRMED THERE WAS NO HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CONSUMER CONFIRMED THERE WAS NO DELAY OR IMPACT TO THEIR TREATMENT.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED EIGHT (8) FALSE NEGATIVE RESULTS AMONG THREE (3) CONSUMERS WITH THE BINAXNOW COVID-19 SELF-TEST PERFORMED ON VARIOUS DATES. THIS MFR. REPORT ADDRESSES TEST EIGHT (8) OF EIGHT (8); CONSUMER (TWO) 2 OR THREE (3) OF THREE (3). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 SELF-TEST PERFORMED ON BETWEEN (B)(6) 2023 ON A NASAL SWAB. ADDITIONAL TESTING WAS PERFORMED WITH A QUICKVIEW ANTIGEN TEST GENERATING A POSITIVE RESULT ON AN UNKNOWN DATE. THE CONSUMER CONFIRMED THERE WAS NO HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CONSUMER CONFIRMED THERE WAS NO DELAY OR IMPACT TO THEIR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1764478 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 221038 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown