MAUDE Adverse Event Report: INFUSION DEVICES - UNKNOWN

Lot Number UNKNOWN

Device Problem Material Deformation (2976)

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's mother that the patient was hospitalized for three separate times within the span of 1 week (from (b)(6) 2020 to (b)(6) 2020).Initially, he was hospitalized for a low blood glucose level of 17 mg/dl on (b)(6) 2020 and twice more for high blood glucose level of 1100 mg/dl and above 800 mg/dl within the next week - exact incident dates unknown).Reportedly, for treating high blood glucose level of 1100 mg/dl, the patient was administered insulin drip intravenously and had an overnight stay in the emergency room.Further, it was also found that the tubing was bent a few times.Currently, (at the time of the report) the patient's blood glucose level was 1100 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: 11383296
• MDR Text Key: 233769338
• Report Number: 3003442380-2021-00160
• 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

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 12/04/2020
• Type of Device Usage: N
• Patient Sequence Number: 1