BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 18428875 · Received January 2, 2024

    Report

    Report Number
    1221359-2024-00005
    Event Type
    Malfunction
    Date Received
    January 2, 2024
    Date of Event
    December 9, 2023
    Report Date
    February 27, 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

    D4: 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: OTHER - DEVICE NOT RETURNED; SINGLE USE DEVICE.

    Additional Manufacturer Narrative · 0

    UDI: (B)(4) ADDITIONAL INFORMATION: B5 - UPDATED EVENT, H6: MEDICAL DEVICE PROBLEM CODE THE LOT NUMBER OF THE SECOND TEST IS UNKNOWN, IT WAS NOT PROVIDED BY THE CUSTOMER. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO UPDATE THE PREVIOUSLY REPORTED EVENT OF A FALSE POSITIVE RESULT. NEW INFORMATION WAS PROVIDED, AND UPON REVIEW IT HAS BEEN DETERMINED THERE IS NO EVIDENCE OF A FALSE POSITIVE OR PRODUCT MALFUNCTION. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 225161 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 225161, TEST BASE PART NUMBER 195-430H/ LOT 221919. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE AND FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 225161 SHOWED THAT THE COMPLAINT RATE IS (B)(4) AND (B)(4) RESPECTIVELY. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, HOWEVER IT COULD HAVE POSSIBLY BEEN RELATED TO THE SPECIFIC PATIENT SAMPLE. H3 OTHER TEXT : OTHER - DEVICE NOT RETURNED; SINGLE USE DEVICE.

    Additional Manufacturer Narrative · 0

    D4: UDI: (B)(4). THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. H3 OTHER TEXT: OTHER: DEVICE NOT RETURNED; SINGLE USE DEVICE.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH BINAXNOW COVID-19 AG SELF TEST ON AN UNKNOWN DATE WITH AN UNKNOWN SAMPLE. ADDITIONAL TESTING WAS PERFORMED ON AN UNKNOWN DATE GENERATING A POSITIVE TEST RESULT. NO ADDITIONAL INFORMATION, INCLUDING TREATMENT, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED CONFLICTING RESULTS WITH BINAXNOW COVID-19 AG SELF TEST. TESTING WAS PERFORMED ON(B)(6)2023 (LOT: 225161) GENERATING A POSITIVE RESULT. REPEAT TESTING WAS PERFORMED ON AN UNKNOWN DATE (LOT: UNKNOWN) GENERATING A NEGATIVE TEST RESULT. THE CONSUMER STATED THE PATIENT WAS ASYMPTOMATIC. NO ADDITIONAL INFORMATION, INCLUDING TREATMENT, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH BINAXNOW COVID-19 AG SELF TEST ON AN UNKNOWN DATE WITH AN UNKNOWN SAMPLE. ADDITIONAL TESTING WAS PERFORMED ON AN UNKNOWN DATE GENERATING A NEGATIVE TEST RESULT. NO ADDITIONAL INFORMATION, INCLUDING TREATMENT, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1450802 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 225161 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female