MAUDE Adverse Event Report: QUIDEL CORP. QUIDEL SOFIA 2; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/10/2020

Event Type  malfunction  

Event Description

Sixty-four positive sars-cov-2 antigen tests at one urgent care clinic (b)(6) between (b)(6) 2020.The clinic is using the quidel sofia 2.Subsequent pcr testing for these individuals (average 2 days after antigen tests) were: pcr negative 51, pcr positive 4, no pcr done 9, all 4 pcr positive patients had symptoms consistent with covid-19 as well as possible exposure to a case (2 through out of state travel and 2 through household contact).Symptomatology for these individuals: 42 with no symptoms, 6 unknown whether symptomatic, 6 with symptoms consistent with the covid-19 probable case definition, 10 symptoms not consistent with the covid-19 probable case definition.The clinic did not use vtm for the sophia test.It only used what's in the package ("a reagent solution not vtm").The clinic ran the instrument in both batch and individual mode.The clinic did not record whether it operated the machine in individual or batch mode, but plans to keep a log of that going forward.For example, if a family of 5 came in for testing, the clinic might have run the tests as a batch.The clinic ran the calibration every day.The clinic ran positive and negative controls when changing the lot number.The clinic threw away the boxes after use and therefore does not have lot #s for the tests performed since (b)(6).The clinic will try to access lot number information from the (b)(6).It is currently using lot # 141328 (beginning (b)(6), with zero positive from that lot so far).The clinic has two sophia 2 instruments.Serial number for sophia 2 a: (b)(4), serial number for sophia 2 b: (b)(4), reference number on both instruments: (b)(4).Fda safety report id# (b)(4).

• Brand Name: QUIDEL SOFIA 2
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORP.
• MDR Report Key: 10319525
• MDR Text Key: 200439400
• Report Number: MW5095680
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/21/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other