MAUDE Adverse Event Report: INFUSION DEVICES - UNKNOWN

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.On (b)(6) 2023, the patient's mother reported that her child faced an insulin flow block and the patient experienced weakness, difficulty in breathing, extremity pain/cramps, vomiting and had high ketone level.Therefore, on (b)(6) 2022, the patient was hospitalized due to diabetic ketoacidosis with high blood glucose level of 750 mg/dl.During hospitalization, the patient received insulin drip intravenously as corrective treatment.After staying for one and a half week in the hospital, the patient was released.Currently, the patient's blood glucose level was 189 mg/dl.No further information available.

• Brand Name: INFUSION DEVICES - UNKNOWN
• Type of Device: INFUSION DEVICES - UNKNOWN
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 16200870
• MDR Text Key: 307660390
• Report Number: 3003442380-2023-00127
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• 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: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 01/13/2023
• Initial Date FDA Received: 01/19/2023
• Patient Sequence Number: 1