MAUDE Adverse Event Report: AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT

Model Number 1002817

Device Problem Appropriate Term/Code Not Available (3191)

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 experienced high blood glucose level as the infusion set was not fully inserted in the body. Therefore, the patient tried to treat it with a bolus via the pump, but on (b)(6) 2021, she went to the emergency room due to diabetic ketoacidosis. Her highest blood glucose level was 500 mg/dl and the infusion had been used for one day. The patient had high ketone levels which the healthcare professional assessed not to be dangerous/life threatening. During her stay in the emergency room, she received fluids of saline, insulin and unspecified medication (drug name unknown) intravenously, which resolved the issue. On (b)(6) 2021, the patient was released from the emergency room with no permanent damage to the patient. Previously, on (b)(6) 2021 and (b)(6) 2021 went to the emergency room due to same issue. Her highest blood glucose level was 1100 mg/dl for both emergency visits. On (b)(6) 2021 and (b)(6) 2021, the patient was released from the emergency room, respectively. No further information available.

• Brand Name: AUTOSOFT 90
• Type of Device: UNO INSET II 60/6 GREY TCAP 10PK INT
• MDR Report Key: 12597043
• MDR Text Key: 275366839
• Report Number: 3003442380-2021-00536
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• PMA/PMN Number: K032854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 10/08/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 1002817
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No Answer Provided

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/28/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage