MAUDE Adverse Event Report: SMITHS MEDICAL CLEO INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Hyperglycemia (1905)

Event Date 02/23/2013

Event Type  Injury  

Event Description

In accordance with 21 cfr 803.22 (b) (2), we are notifying you that on (b)(6) 2013, the patient reported that on (b)(6) 2013 she was feeling sick and her son called 911.Emts arrived and took her to the hospital.While in the er her blood glucose level was 960 mg/dl.Her target blood glucose level is 135 mg/dl.The patient was using competitor's infusion set during the time of the incident.The patient was in the a hospital for seven days.She received and iv and injections of insulin.The patient stated that her infusion device had displayed e4 (occlusion errors) in the past.She stated that her doctor was unsure of what caused the elevated blood glucose level.The cleo infusion set mentioned in this event is not manufactured by our firm.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CLEO INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL
• MDR Report Key: 17525896
• MDR Text Key: 321069353
• Report Number: MW5132837
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1