BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW RSV WAIVED 22T

    MDR report key: 18952604 · Received March 21, 2024

    Report

    Report Number
    1221359-2024-00292
    Event Type
    Malfunction
    Date Received
    March 21, 2024
    Date of Event
    February 21, 2024
    Report Date
    April 23, 2024
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    GQG
    UDI-DI
    10811877011191
    PMA / PMN Number
    K032166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4-UDI: (B)(4). ABBOTT MEDICAL AFFAIRS DECISION DETERMINED THIS FALSE NEGATIVE RESULT SHOULD BE CONSERVATIVELY REPORTED AS A MALFUNCTION. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 817326 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: 817326, TEST BASE PART NUMBER 430-430/ LOT: 798126. 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 817326 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    D4-UDI:((B)(4)ABBOTT MEDICAL AFFAIRS DECISION DETERMINED THIS FALSE NEGATIVE RESULT SHOULD BE CONSERVATIVELY REPORTED AS A MALFUNCTION.THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW RSV WAIVED 22T PERFORMED ON (B)(6) 2024 ON A NASOPHARYNGEAL SAMPLE. PER THE CUSTOMER, THE PATIENT WAS SYMPTOMATIC AND THEIR SYMPTOMS WORSENED THE NEXT DAY. THEY WERE HOSPITALIZED ON (B)(6) 2024 DUE TO LOW OXYGEN WHERE CONFIRMATION TESTING WAS PERFORMED VIA AN UNKNOWN METHOD WHICH GENERATED A POSITIVE RESULT. THE PATIENT WAS HOSPITALIZED FOR A TOTAL OF TWO (2) NIGHTS AND RECEIVED SUPPLEMENTAL OXYGEN AND NEBULIZER TREATMENTS. THE PATIENT WAS TREATED WITH A DOSE OF DEXAMETHASONE. THE PATIENT IS REPORTED TO HAVE RECOVERED AND IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW RSV WAIVED 22T PERFORMED ON (B)(6)2024 ON A NASOPHARYNGEAL SAMPLE. PER THE CUSTOMER, THE PATIENT WAS SYMPTOMATIC AND THEIR SYMPTOMS WORSENED THE NEXT DAY. THEY WERE HOSPITALIZED ON (B)(6)2024 DUE TO LOW OXYGEN WHERE CONFIRMATION TESTING WAS PERFORMED VIA AN UNKNOWN METHOD WHICH GENERATED A POSITIVE RESULT. THE PATIENT WAS HOSPITALIZED FOR A TOTAL OF TWO (2) NIGHTS AND RECEIVED SUPPLEMENTAL OXYGEN AND NEBULIZER TREATMENTS. THE PATIENT WAS TREATED WITH A DOSE OF DEXAMETHASONE. THE PATIENT IS REPORTED TO HAVE RECOVERED AND IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891777 BINAXNOW RSV WAIVED 22T ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS GQG ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 817326 10811877011191

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female