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

Model Number 20274

Device Problem Chemical Spillage (2894)

Patient Problem Red Eye(s) (2038)

Event Date 04/12/2018

Event Type  Injury  

Manufacturer Narrative

The test and reagent vial were not returned to quidel for evaluation.However, the qc department evaluated retained vials from the same lot.All vials met the inspection criteria - free of holes, splits, etc.No leakage or moisture was evident.A sample of vials were opened per the instructions for use, and no issues were observed.

Event Description

When opening a strep a reagent solution vial, the solution splashed into the right eye of the operator which caused stinging and burning.The operator went to a doctor who provided antibiotic eye drops.The eye healed in two days.

• Brand Name: SOFIA STREP A+ FIA
• Type of Device: STREP A 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: 7495325
• MDR Text Key: 107634213
• Report Number: 2024674-2018-00002
• Device Sequence Number: 1
• Product Code: GTY
• UDI-Device Identifier: 30014613202745
• UDI-Public: 30014613202745
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141775
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2018
• Device Model Number: 20274
• Device Lot Number: 703212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention