BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BINAXNOW RSV WAIVED 22T

    MDR report key: 18615655 · Received January 31, 2024

    Report

    Report Number
    1221359-2024-00124
    Event Type
    Injury
    Date Received
    January 31, 2024
    Date of Event
    January 1, 2024
    Report Date
    February 21, 2024
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    GQG
    UDI-DI
    10811877011191
    PMA / PMN Number
    K032166
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FDA UDI - (B)(4). B3: THE DATE INDICATED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED. PER MEDICAL OPINION, IT IS UNCLEAR WHAT CONTRIBUTION OF THE ALLEGED FALSE NEGATIVE CONTRIBUTED TO THE HOSPITALIZATION/VENTILATION LIFE-THREATENING (THERE IS NO SPECIFIC RSV TREATMENT). THERE WAS NO INDICATION THAT THE NEGATIVE RESULT CONTRIBUTED TO PATIENT HOSPITALIZATION AND VENTILATION (PATIENT WAS VERY SICK BEFORE TESTING AND THE TREATMENT OF RSV ARE MOSTLY SYMPTOM RELIEVING). THIS EVENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 777906W 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 430-122/ LOT 777906W AND TEST BASE PART NUMBER 430-430 / LOT 774019. 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 777906W SHOWED THAT THE COMPLAINT RATE IS (B)(4)%. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    FDA UDI - (B)(4). THE DATE INDICATED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED. PER MEDICAL OPINION, IT IS UNCLEAR WHAT CONTRIBUTION OF THE ALLEGED FALSE NEGATIVE CONTRIBUTED TO THE HOSPITALIZATION/VENTILATION LIFE-THREATENING (THERE IS NO SPECIFIC RSV TREATMENT). THERE WAS NO INDICATION THAT THE NEGATIVE RESULT CONTRIBUTED TO PATIENT HOSPITALIZATION AND VENTILATION (PATIENT WAS VERY SICK BEFORE TESTING AND THE TREATMENT OF RSV ARE MOSTLY SYMPTOM RELIEVING). THIS EVENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAX NOW RSV TEST ON AN UNKNOWN DATE WITH AN UNKNOWN SAMPLE TYPE. PER THE CUSTOMER, PRIOR TO INITIAL TESTING, THE PATIENT WAS "REALLY SICK." FOLLOWING THE FALSE RESULT AND PATIENT'S SUBSEQUENT DEPARTURE, THE PATIENT STOPPED BREATHING AND WAS SENT TO A DIFFERENT HOSPITAL WHERE THE PATIENT TESTED POSITIVE FOR RSV ON AN UNKNOWN PLATFORM. THE PATIENT WAS REPORTED TO BE ON A VENTILATOR AS OF 05JAN2024. ALTHOUGH REQUESTED, NO FURTHER INFORMATION INCLUDING TREATMENT AND OUTCOME WAS PROVIDED. NO ADDITIONAL INFORMATION INCLUDING TREATMENT AND OUTCOME WAS PROVIDED. ATTEMPTS TO OBTAIN THIS INFORMATION ARE ONGOING.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW RSV TEST ON AN UNKNOWN DATE WITH AN UNKNOWN SAMPLE TYPE. PER THE CUSTOMER, PRIOR TO INITIAL TESTING, THE PATIENT WAS "REALLY SICK." FOLLOWING THE FALSE RESULT AND PATIENT'S SUBSEQUENT DEPARTURE, THE PATIENT STOPPED BREATHING AND WAS SENT TO A DIFFERENT HOSPITAL WHERE THE PATIENT TESTED POSITIVE FOR RSV ON AN UNKNOWN PLATFORM. THE PATIENT WAS REPORTED TO BE ON A VENTILATOR AS OF 05JAN2024. ALTHOUGH REQUESTED, NO FURTHER INFORMATION INCLUDING TREATMENT AND OUTCOME WAS PROVIDED. NO ADDITIONAL INFORMATION INCLUDING TREATMENT AND OUTCOME WAS PROVIDED. ATTEMPTS TO OBTAIN THIS INFORMATION ARE ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393274 BINAXNOW RSV WAIVED 22T ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS GQG ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 777906W 10811877011191

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R