BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 18610439 · Received January 30, 2024

    Report

    Report Number
    1221359-2024-00122
    Event Type
    Malfunction
    Date Received
    January 30, 2024
    Date of Event
    January 1, 2024
    Report Date
    March 15, 2024
    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

    FDA UDI - (B)(4). B3: THE DATE INDICATED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    FDA UDI (B)(4). B3: THE DATE INDICATED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 227508B 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 195-160 / LOT 227508B AND TEST BASE PART NUMBER 195-430H / LOT 223640. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 227508B 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 HAVE POSSIBLY BEEN RELATED TO ISSUES INCLUDING THE SELF-TEST USER PERFORMANCE, INTERPRETATION OF THE RESULT, OR THE SPECIFIC PATIENT SAMPLE. SINGLE USE; DEVICE DISCARDED.

    Description of Event or Problem · 0

    SPOUSE REPORTED FALSE NEGATIVE RESULTS ON BEHALF OF THE CONSUMER WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON UNKNOWN DATES. THIS MANUFACTURER'S REPORT ADDRESSES TEST TWO (2) OF TWO (2). REPEAT TESTING WAS PERFORMED AND GENERATED A NEGATIVE TEST. CONSUMER HAS BEEN COVID POSITIVE FOR A WEEK, WHICH WAS CONFIRMED AT HOME AND AT HER WORKPLACE. ALTHOUGH REQUESTED, THE BRAND(S) USED ARE UNKNOWN. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    SPOUSE REPORTED FALSE NEGATIVE RESULTS ON BEHALF OF THE CONSUMER WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON UNKNOWN DATES. THIS MANUFACTURER'S REPORT ADDRESSES TEST TWO (2) OF TWO (2). REPEAT TESTING WAS PERFORMED AND GENERATED A NEGATIVE TEST. CONSUMER HAS BEEN COVID POSITIVE FOR A WEEK, WHICH WAS CONFIRMED AT HOME AND AT HER WORKPLACE. ALTHOUGH REQUESTED, THE BRAND(S) USED ARE UNKNOWN. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392934 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 227508B 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female