MAUDE Adverse Event Report: QUIDEL CORPORATION SOFIA RSV FIA; RSV TEST

Model Number 20260

Device Problem False Negative Result (1225)

Patient Problem Respiratory Tract Infection (2420)

Event Date 12/25/2019

Event Type  Injury  

Manufacturer Narrative

The following investigation steps were performed: testing: the customer returned tests from kit lot #705337 (pouch lot #135981).Five (5) returned devices were testing with rsv low-level positive standard.All five (5) returned devices tested with rsv low-level positive standard yielded 100% valid and positive results at the 15 minute result read time.Device history record (dhr) review: a review of the dhr was conducted and no issues were noted.The devices were released in accordance to their specifications.Analyzer log data review: an analysis of the returned log data was performed.Four (4) tests were conducted with pouch lot #135981: two (2) tests had positive results and two(2) tests had negative results.The customer reported that the patient was tested on (b)(6) 2019 and again on (b)(6) 2019; no patient id was provided.The logs show that on the reported dates, there was only one rsv test performed on each of those dates and both tests were negative.Although sofia rsv is a qualitative test, quantitative values are recorded in the log.The quantitative valued are for information only, and they do not fully represent the test.For the test performed on (b)(6) 2019, the signal to cutoff (s/co) value = 0.26, and for the test performed on (b)(6) 2019, the s/co value was 0.25.S/co values below 1.0 on sofia will be reported as negative.The s/co values and dates for the two positive results in the log data were 26.13 on (b)(6) 2019 and 45.25 on (b)(6) 2019.Trend data: trend analysis was performed for the sofia rsv.No trend was identified.Conclusion: we tested the returned devices with the rsv low-level positive standard in our qc laboratory, and the devices yielded 100% valid and positive results at the 15 minute result read time.Log data review shows that sofia rsv performed correctly.The s/co negative values support that negative results were noted on (b)(6).A review of the manufacturing data showed that product passed all tests and was released in accordance to our specification.Trend analysis was performed and no fn trend was identified for this lot, and these were the only two fns.Although we were unable to duplicate the complaint, the information provided has been documented and will continue to be monitored as part of our quality system.

Event Description

On (b)(6), an infant with rsv-like symptoms tested negative for rsv at the er and was sent home.On (b)(6) the infant was brought back to the er and tested negative for rsv again.The patient was then transferred same day to (b)(6) and was tested with the biofire rp panel.The pcr came back positive for rsv.The infant developed pneumonia and was rushed into the icu same day (12/26) was released on (b)(6) 2019.

• Brand Name: SOFIA RSV FIA
• Type of Device: RSV TEST
• Manufacturer (Section D): QUIDEL CORPORATION; 10165 mckellar court; san diego CA 92121
• Manufacturer (Section G): QUIDEL CORPORATION; 10165 mckellar court; san diego CA 92121
• Manufacturer Contact: jennifer rial ; 10165 mckellar court; san diego, CA 92121 ; 8585527910
• MDR Report Key: 9627958
• MDR Text Key: 178260454
• Report Number: 2024674-2020-00001
• Device Sequence Number: 1
• Product Code: GQG
• UDI-Device Identifier: 30014613202608
• UDI-Public: 0130014613202608
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162911
• 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
• Report Date: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2021
• Device Model Number: 20260
• Device Lot Number: 705337
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2019
• 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 Outcome(s): Hospitalization
• Patient Age: 5 MO
• Patient Weight: 8