MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CLEO® 90 6MM X 31" INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Hyperglycemia (1905); Rash (2033)

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

It was reported that while a patient was using a cleo 90 infusion set, the adhesive was not sticking and would leave a rash on the skin for 2 weeks.The customer believes that "the box was old from the distributor".The customer was able to send box back to the distributor, and then she was sent a replacement box.While consulting with technical support about this event, the customer reported a blood glucose reading of 284 mg/dl, but she did not test for the presence ketones.To resolve the high blood glucose reading, the patient removed the insulin pump and performed a correction bolus via injection.Technical support instructed the patient to consult with her health care provider regarding proper skin preparation and other products that would assist with an improved application and use of the device set.No further adverse health outcomes were reported.See mfr: 3012307300-2017-00241 3012307300-2017-00242 3012307300-2017-00244 3012307300-2017-00245 3012307300-2017-00246.

• Brand Name: CLEO® 90 6MM X 31" 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.; parque industrial internaciona; tijuana, b.c. 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6282607
• MDR Text Key: 65941256
• Report Number: 3012307300-2017-00243
• 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,distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2017
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 103