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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 02/01/2012

Event Type  Injury  

Event Description

In accordance with 21 cfr 803.22 (b)(2), we are notifying you that on (b)(6) 2012, a patient reported being hospitalized on (b)(6) 2012 due to hypoglycemia.She lost consciousness and was transported to the hospital by paramedics where she received an iv.She was discharged around 12:45 a.M.On (b)(6) 2012, the patient does not know what caused this hypoglycemic event, and her basal rates have since been decreased by her healthcare professional.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: 17529689
• MDR Text Key: 321136373
• Report Number: MW5136613
• 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: 05/31/2012

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