MAUDE Adverse Event Report: TRUSTEEL; UNO CONTACT DETACH G29 80/8TCAP 10PK INT

Lot Number UNKNOWN

Device Problem Infusion or Flow Problem (2964)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.It was reported that the patient faced an occlusion alarm and she experienced high blood glucose level.They tried to treat it with bolus via pump and multiple daily injection (mdi).Therefore, on (b)(6) 2024, the patient first went to the emergency room and was subsequently hospitalized due to diabetic ketoacidosis and high blood glucose level.Her highest blood glucose level was 600 mg/dl.Moreover, the infusion set was used for one hour.During hospitalization, the patient received saline (unknown), insulin, multiple daily injection (mdi), and unspecified medication (drug name unknown) intravenously, as corrective treatment which resolved the issue.On (b)(6) 2024, the patient was released from the hospital with no permanent damage.Since her release, her blood glucose levels have been elevated.No further information was available.

• Brand Name: TRUSTEEL
• Type of Device: UNO CONTACT DETACH G29 80/8TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18805798
• MDR Text Key: 336509647
• Report Number: 3003442380-2024-00165
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K041545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 02/22/2024
• Patient Sequence Number: 1