BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAX NOW COVID-19 AG CARD KIT 40T EUA

    MDR report key: 16372973 · Received February 14, 2023

    Report

    Report Number
    1221359-2023-00303
    Event Type
    Malfunction
    Date Received
    February 14, 2023
    Date of Event
    February 1, 2023
    Report Date
    April 28, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    10811877011290
    PMA / PMN Number
    EUA202537
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. SINGLE USE, DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    B5: THE CUSTOMER REPORTED THAT ONE (1) OF THE TWO (2) PATIENTS WAS SYMPTOMATIC AT THE TIME OF TESTING BUT WAS UNABLE TO DETERMINE WHICH DATE THE SYMPTOMATIC PATIENT TOOK THE TEST. H3 OTHER TEXT : SINGLE USE, DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 193255 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 KIT PART NUMBER 195-000/ LOT 193255 AND DEVICE PART NUMBER 195-430H/ LOT 189016. 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 193255 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 POSSIBLY BE RELATED TO THE SPECIFIC PATIENT SAMPLES. H3 OTHER TEXT : SINGLE USE, DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED 5 (FIVE) FALSE NEGATIVES WITH THE BINAXNOW COVID-19 ANTIGEN CARD EXTENDED EXPIRATION DATE PERFORMED ON MULTIPLE DAYS. THIS MFR. REPORT ADDRESSES TEST 1 (ONE) OF 5 (FIVE). ON (B)(6) 2023 A PATIENT WAS TESTED WITH BINAXNOW COVID-19 ANTIGEN CARD LOT 193255 AND GENERATED A NEGATIVE RESULT. HOWEVER, THE CUSTOMER THOUGHT THE PATIENT SHOULD BE POSITIVE FOR COVID-19. THE CUSTOMER STATED THAT THE PATIENT WAS UNABLE TO RECEIVE COVID-19 SPECIFIC TREATMENT DUE TO THE NEGATIVE TEST RESULT. HOWEVER, THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TWO (2) FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN CARD FOR TWO (2) SEPARATE TESTS AND PATIENTS PERFORMED BETWEEN (B)(6) 2023. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF TWO (2). THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN CARD PERFORMED ON 01FEB2023 ON A NASAL SWAB. ADDITIONAL TESTING WAS PERFORMED ON 06FEB2023 WITH AN ADDITIONAL BINAXNOW COVID-19 ANTIGEN CARD USING A NASAL SWAB THAT GENERATED A POSITIVE RESULT. CONFIRMATION TESTING WAS NOT PERFORMED. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED. THE CUSTOMER REPORTED THAT THE PATIENT WAS UNABLE TO RECEIVE COVID-19 MEDICATION DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER REPORTED THE RESULTS MAY HAVE "POTENTIALLY CONTRIBUTED TO THE FURTHER SPREAD OF COVID AND POSSIBLE DELAY OF TREATMENT" FOR OTHERS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TWO (2) FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN CARD FOR TWO (2) SEPARATE TESTS AND PATIENTS PERFORMED BETWEEN (B)(6) 2023. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF TWO (2). THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN CARD PERFORMED ON (B)(6) 2023 ON A NASAL SWAB. ADDITIONAL TESTING WAS PERFORMED ON (B)(6) 2023 WITH AN ADDITIONAL BINAXNOW COVID-19 ANTIGEN CARD USING A NASAL SWAB THAT GENERATED A POSITIVE RESULT. CONFIRMATION TESTING WAS NOT PERFORMED. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED. THE CUSTOMER REPORTED THAT THE PATIENT WAS UNABLE TO RECEIVE COVID-19 MEDICATION DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER REPORTED THE RESULTS MAY HAVE "POTENTIALLY CONTRIBUTED TO THE FURTHER SPREAD OF COVID AND POSSIBLE DELAY OF TREATMENT" FOR OTHERS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810054 BINAX NOW COVID-19 AG CARD KIT 40T EUA CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 193255 10811877011290

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other