BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 18575698 · Received January 24, 2024

    Report

    Report Number
    1221359-2024-00110
    Event Type
    Malfunction
    Date Received
    January 24, 2024
    Date of Event
    January 2, 2024
    Report Date
    February 6, 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). 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

    D4-UDI(B)(4). TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 217908 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: 217908, TEST BASE PART NUMBER 195-430H/ LOT: 215162. 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 217908 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD HAVE POSSIBLY BEEN RELATED TO THE SPECIFIC PATIENT SAMPLE.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2024 ON AN UNKNOWN SAMPLE TYPE. ADDITIONAL TESTING WAS PERFORMED TWICE ON THE SAME DAY USING SIEMENS RAPID COVID-19 AG CLINITESTS WHICH GENERATED NEGATIVE RESULTS. CONFIRMATION TESTING WAS PERFORMED ON THE SAME DAY VIA PCR (PLATFORM: UNKNOWN) WHICH GENERATED A NEGATIVE RESULT. THE CONSUMER CONFIRMED THERE WAS NO TREATMENT OR MEDICINE RECEIVED OTHER THAN TYLENOL. NO ADDITIONAL INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2024 ON AN UNKNOWN SAMPLE TYPE. ADDITIONAL TESTING WAS PERFORMED TWICE ON THE SAME DAY USING SIEMENS RAPID COVID-19 AG CLINITESTS WHICH GENERATED NEGATIVE RESULTS. CONFIRMATION TESTING WAS PERFORMED ON THE SAME DAY VIA PCR (PLATFORM: UNKNOWN) WHICH GENERATED A NEGATIVE RESULT. THE CONSUMER CONFIRMED THERE WAS NO TREATMENT OR MEDICINE RECEIVED OTHER THAN TYLENOL. NO ADDITIONAL INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2406476 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 217908 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown