MAUDE Adverse Event Report: SMITHS HEALTHCARE MFG CLEO® 90 INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-7230-24

Device Problems Failure To Adhere Or Bond (1031); Separation Failure (2547); Device Operates Differently Than Expected (2913)

Patient Problem Hyperglycemia (1905)

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.

Event Description

The patient called in the reported event on a group of cleo 90 devices that are sticking to the inserter or not adhering to the skin.The patient's blood glucose elevated to 380mg/dl and manual injections were performed to resolve.The patient couldn't remember the exact dates(s) that customer experience occurred.Unknown patients condition at this time.Please reference mdr#s: 2183502-2016-01552, 2183502-2016-01553, 2183502-2016-01555, 2183502-2016-01556, 2183502-2016-01557, 2183502-2016-01558, 2183502-2016-01559, 2183502-2016-01560, 2183502-2016-01561, 2183502-2016-01562, 2183502-2016-01563, 2183502-2016-01564, 2183502-2016-01565, 2183502-2016-01566, 2183502-2016-01567, 2183502-2016-01568, 2183502-2016-01569 and 2183502-2016-01570 that are also associated with this complaint.

• Brand Name: CLEO® 90 INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS HEALTHCARE MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana 55425 ; MX 55425
• Manufacturer (Section G): SMITHS HEALTHCARE MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana 55425 ; MX 55425
• Manufacturer Contact: lisa perz ; 1265 grey fox rd; st. paul, MN 55112 ; 7633833074
• MDR Report Key: 5814474
• MDR Text Key: 50175905
• Report Number: 2183502-2016-01554
• 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: 06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/28/2021
• Device Catalogue Number: 21-7230-24
• Device Lot Number: 76X039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2016
• 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): Required Intervention