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)2017, the patient's mother reported that her son had first day of school and he experienced vomiting and high blood glucose level of 538 mg/dl due to insulin blockage.Therefore, on (b)(6) 2017 at 08:00 pm, the patient was admitted to the hospital due to diabetic ketoacidosis (as per healthcare professional) with blood glucose level of 359 mg/dl.The patient last changed the infusion set on (b)(6)2017.Reportedly, the patient was still hospitalized at the time of this report ( (b)(6) 2017).Currently, his blood glucose level was 153 mg/dl.No further information available.

• Brand Name: INFUSION DEVICES - UNKNOWN
• Type of Device: INFUSION DEVICES - UNKNOWN
• MDR Report Key: 12517931
• MDR Text Key: 272859245
• Report Number: 3003442380-2021-00497
• 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
• Type of Report: Initial

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 Operator: No Information
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 09/15/2021
• Initial Date FDA Received: 09/23/2021
• Type of Device Usage: N
• Patient Sequence Number: 1