BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAX NOW COVID-19 AG CARD

    MDR report key: 11136875 · Received January 7, 2021

    Report

    Report Number
    1221359-2021-00048
    Event Type
    Malfunction
    Date Received
    January 7, 2021
    Date of Event
    December 8, 2020
    Report Date
    March 25, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    10811877011290
    PMA / PMN Number
    EUA202537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D4, H4, H6: INVESTIGATION TYPE/FINDINGS/CONCLUSION. H10: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 128003 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 128003 AND DEVICE PART NUMBER 195-430H / LOT 126334A. 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 128003 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD POSSIBLY BE RELATED TO THE SPECIFIC PATIENT SAMPLES.

    Additional Manufacturer Narrative · 1

    REFERENCE MANUFACTURER REPORTS: 1221359-2021-00033, 1221359-2021-00034, 1221359-2021-00035, 1221359-2021-00036, 1221359-2021-00047. THE INVESTIGATION IS STILL IN PROGRESS, A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE BINAX NOW COVID-19 AG CARD OVER A PERIOD OF 3 WEEKS INVOLVING TWO PATIENTS. THIS REPORT ADDRESSES PATIENT TWO(2) OF TWO (2) RELATED TO THE EVENT RELATED LOT NUMBER 128003 (ADDITIONAL TESTING). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT DURING ADDITIONAL TESTING OF PATIENT 2 ON (B)(6) 2020. THE CUSTOMER DID NOT PROVIDE SAMPLING DETAILS PERTAINING TO REPEAT OR CONFIRMATION TESTING. THE CUSTOMER STATED THE PATIENT WAS NOT SYMPTOMATIC. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT. PER BINAXNOW COVID-19 AG CARD PRODUCT INSERT INTENDED USE: POSITIVE RESULTS INDICATE THE PRESENCE OF VIRAL ANTIGENS, BUT CLINICAL CORRELATION WITH PATIENT HISTORY AND OTHER DIAGNOSTIC INFORMATION IS NECESSARY TO DETERMINE INFECTION STATUS. POSITIVE RESULTS DO NOT RULE OUT BACTERIAL INFECTION OR CO-INFECTION WITH OTHER VIRUSES. THE AGENT DETECTED MAY NOT BE THE DEFINITE CAUSE OF DISEASE. PER BINAXNOW COVID-19 AG CARD PRODUCT INSERT INTENDED USE (LIMITATIONS): FALSE RESULTS MAY OCCUR IF SPECIMENS ARE TESTED PAST 1 HOUR OF COLLECTION. SPECIMENS SHOULD BE TESTED AS QUICKLY AS POSSIBLE AFTER SPECIMEN COLLECTION. DUE TO THE RISK OF A FALSE POSITIVE RESULT LEADING TO POSSIBLE EXPOSURE TO COVID-19 THROUGH THE QUARANTINE OF THE FALSE POSITIVE PATIENT WITH TRUE POSITIVE PATIENT(S), DELAYED EMERGENCY TREATMENT AND/OR INAPPROPRIATE TREATMENT WITH ANTIVIRAL THERAPY, THE INCIDENT SHALL BE CONSIDERED REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32057 BINAX NOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 128003 10811877011290

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR