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

Catalog Number 430-122

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2024

Event Type  malfunction  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 338431182
• Report Number: 1221359-2024-00292
• Device Sequence Number: 1
• Product Code: GQG
• UDI-Device Identifier: 10811877011191
• UDI-Public: 10811877011191
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 430-122
• Device Lot Number: 817326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: 04/17/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/30/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female