MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW RSV WAIVED 22T; ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS

Catalog Number	430-122
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: BINAXNOW RSV WAIVED 22T
• Common Device Name: ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: rachel blackwell ; 10 southgate road; scarborough, ME 04074 ; 6613888803
• MDR Report Key: 18952604
• Report Number: 1221359-2024-00292
• Device Sequence Number: 7050611
• Product Code: GQG
• UDI-Device Identifier: 10811877011191
• UDI-Public: 10811877011191
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K032166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/23/2025
• Device Catalogue Number: 430-122
• Device Lot Number: 817326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female