BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 17477990 · Received August 8, 2023

    Report

    Report Number
    1221359-2023-01319
    Event Type
    Malfunction
    Date Received
    August 8, 2023
    Date of Event
    July 13, 2023
    Report Date
    August 15, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 211595 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 211595, TEST BASE PART NUMBER 195-430H / LOT 207161. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 211595 SHOWED THAT THE COMPLAINT RATE IS (B)(4). IN CONCLUSION, 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.A3 - GENDER H3 OTHER TEXT : SINGLE-USE, DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION OR UPON RECEIPT OF NEW INFORMATION. H3 OTHER TEXT : SINGLE-USE, DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED SEVEN (7) UNCONFIRMED FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST AND BINAXNOW COVID-19 ANTIGEN HOME TEST FOR MULTIPLE TESTS PERFORMED ON DIFFERENT DAYS. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF SEVEN (7) WHICH OCCURRED ON (B)(6) 2023. REPEAT TESTING (X6) WAS PERFORMED AND GENERATED NEGATIVE RESULTS THROUGH (B)(6) 2023. ADDITIONAL TESTING (X7) WAS PERFORMED WITH NON-ABBOTT TEST (PLATFORM - IHEALTH) AND GENERATED POSITIVE RESULTS THROUGH (B)(6) 2023. ADDITIONAL TESTING (X3) WAS PERFORMED WITH NON-ABBOTT TEST (PLATFORM - DIATRUST) AND GENERATED NEGATIVE RESULTS THROUGH (B)(6) 2023. THE CONSUMER WAS DIAGNOSED WITH COVID-19 ON (B)(6) 2023 AND WAS SYMPTOMATIC (FEVER). ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED SEVEN (7) UNCONFIRMED FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF TEST AND BINAXNOW COVID-19 ANTIGEN HOME TEST FOR MULTIPLE TESTS PERFORMED ON DIFFERENT DAYS. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF SEVEN (7) WHICH OCCURRED ON (B)(6) 2023. REPEAT TESTING (X6) WAS PERFORMED AND GENERATED NEGATIVE RESULTS THROUGH (B)(6) 2023. ADDITIONAL TESTING (X7) WAS PERFORMED WITH NON-ABBOTT TEST (PLATFORM - IHEALTH) AND GENERATED POSITIVE RESULTS THROUGH (B)(6) 2023. ADDITIONAL TESTING (X3) WAS PERFORMED WITH NON-ABBOTT TEST (PLATFORM - DIATRUST) AND GENERATED NEGATIVE RESULTS THROUGH (B)(6) 2023. THE CONSUMER WAS DIAGNOSED WITH COVID-19 ON (B)(6) 2023 AND WAS SYMPTOMATIC (FEVER). ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1458531 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 211595 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Male