BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAX NOW COVID-19 AG CARD KIT 40T EUA

    MDR report key: 16043277 · Received December 23, 2022

    Report

    Report Number
    1221359-2022-10407
    Event Type
    Malfunction
    Date Received
    December 23, 2022
    Date of Event
    December 1, 2022
    Report Date
    January 9, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    10811877011290
    PMA / PMN Number
    EUA202537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION: B5 (PCR TEST - CEPHEID NASOPHARYNGEAL SAMPLE). TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 217460 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 195-000 / LOT 217460, TEST BASE PART NUMBER 195-430H / LOT 210888. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE AND PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 217460 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. BASED ON THE ABOVE SUMMARY, THE INVESTIGATION IS DEEMED COMPLETE. THE PRODUCT WILL CONTINUE TO BE MONITORED AND TRACKED. H3 OTHER TEXT : DEVICE DISCARDED, SINGLE USE.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FIVE (5) FALSE POSITIVE RESULTS WITH BINAX NOW COVID-19 AG ON (B)(6) 2022. THE CUSTOMER PERFORMED 5 TESTS ON 5 PATIENTS ON DIFFERENT DATES, AND THEY WERE POSITIVE ON BINAX NOW COVID-19 AG. THE FIVE (5) PATIENTS RECEIVED NEGATIVE RESULTS ON QUIDEL QUICKVUE TEST, AND LATER A CONFIRMATORY TEST (PCR) WAS PERFORMED AND GENERATED NEGATIVE RESULTS AT THE SAME DAY. THIS MFR. REPORT ADDRESSES TEST FOUR (4) OF FIVE (5) TESTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FIVE (5) FALSE POSITIVE RESULTS WITH BINAX NOW COVID-19 AG ON (B)(6) 2022. THE CUSTOMER PERFORMED 5 TESTS ON 5 PATIENTS ON DIFFERENT DATES, AND THEY WERE POSITIVE ON BINAX NOW COVID-19 AG. THE FIVE (5) PATIENTS RECEIVED NEGATIVE RESULTS ON QUIDEL QUICKVUE TEST, AND LATER A CONFIRMATORY TEST (PCR) WAS PERFORMED AND GENERATED NEGATIVE RESULTS AT THE SAME DAY. THIS MFR. REPORT ADDRESSES TEST FOUR (4) OF FIVE (5) TESTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2051018 BINAX NOW COVID-19 AG CARD KIT 40T EUA CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 217460 10811877011290

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown