MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC CLEO® 90 INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-7220-24

Device Problem Kinked (1339)

Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364)

Event Type  Injury  

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.Actual date unknown.Events were reported to have happened between (b)(6) 2016.Possible lot numbers 76x054 or 76x143.Expiration dates: (lot 76x054) march 28, 2021 and (lot 76x143) august 28, 2021.Manufacturing dates: (lot 76x054) march 29, 2016 and (lot 76x143) august 30, 2016.

Event Description

It was reported that the patient had adverse events for two weeks due to cleo® 90 infusion sets along with a t-slim insulin pump.The patient had their first cleo infusion set changed due to high blood glucose around 350mg/dl in which the blood sugar didn't come down.The patient went to the emergency room and subsequently the hospital for 3 days after the second infusion set didn't work as intended and blood sugars rose to 529mg/dl.The patient met with a diabetic educator who found that the second site was kinked the patient was diagnosed with diabetic ketoacidosis in the large range.The patient went home and her blood sugar spiked for the third time around 550mg/dl.The patient started shots immediately which brought her blood sugar down with only moderate ketones.The patient didn't go to the hospital at that time.The outcomes of the events were resolved.No additional information at this time.See mfr number for related events: 3012307300-2017-00294, 3012307300-2017-00296.

• Brand Name: CLEO® 90 INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS HEALTHCARE MFG; s.a de c.v. ave; calidad no. 4,; tijuana, b.c. 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6304313
• MDR Text Key: 66615347
• Report Number: 3012307300-2017-00295
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 21-7220-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention