MAUDE Adverse Event Report: QUIDEL CORPORATION SOFIA INFLUENZA A+B FIA; INFLUENZA TEST

Model Number	20218
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Respiratory Tract Infection (2420)
Date of Event	01/25/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
The clinician reported that sofia influenza a+b fia, lot #703664, was used for testing performed at the (b)(6) clinic.No tests were returned from the clinic because the remaining tests in the kit were used.Two different analyzers were used at the clinic.The clinic provided the data logs to quidel for serial (b)(4) a summary of the data log review and investigation is noted below: data logs: calibration and external qc testing were performed on both analyzers with passing results.No relevant error codes were noted.Only sofia influenza a+b fia cassette lot #126966 was used during the specified timeframe and date provided by the clinic.This cassette lot # was used in kit lot #703733, not kit lot #703664 (the kit lot # reported by the clinic).Kit lot #703733 was released on 11/09/2017, expiration 09/25/2019.Kit lot #703664 was released on 12/01/2017, expiration 10/23/2019 both data logs revealed positive and negative results for testing performed on (b)(6) 2018.No unusual test results were noted.Quidel qc testing: both kit lot numbers (703733 and 703664) were tested with negative, flu a low level qc standard, and flu b low level qc standard.All results were acceptable.The device history records were reviewed for both kit lot numbers, and no false negative results were noted.A complaint analysis for both kit lots was performed, and no trend for false negative results was noted.Conclusion: quidel was unable to duplicate the complaint in our testing, and no unusual results or data were noted in the data logs for both analyzers.
Event or Problem Description
On (b)(6) 2018, the chief medical officer of (b)(6) healthcare contacted quidel regarding a patient who was tested for influenza with the sofia influenza a+b fia.The testing occurred on (b)(6) 2018 at the (b)(6) immediate care facility ((b)(6) location).The test results were negative for influenza a and influenza b.On (b)(6) 2018, the patient was life-flighted to a hospital and tested positive for influenza.On (b)(6) 2018, the patient passed away at the hospital.

• Brand Name: SOFIA INFLUENZA A+B FIA
• Common Device Name: INFLUENZA TEST
• Manufacturer (Section D): QUIDEL CORPORATION; 10165 mckellar court; san diego CA 92121
• MDR Report Key: 7304598
• Report Number: 2024674-2018-00001
• Device Sequence Number: 19306115
• Product Code: PSZ
• UDI-Device Identifier: 30014613202189
• UDI-Public: 30014613202189
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K153012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/25/2019
• Device Model Number: 20218
• Device Lot Number: 703664
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 02/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 15 YR