MAUDE Adverse Event Report: INFUSION DEVICES - UNKNOWN

Lot Number UNKNOWN

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 faced a bent steel cannula issue due to which he experienced high blood glucose level.Therefore, on (b)(6) 2022, the patient first went to the emergency room and was subsequently admitted to the hospital due to high blood glucose level.His highest blood glucose level was 600 mg/dl.Moreover, this event affected other parts of the body as well.Since, the date of admission ((b)(6) 2022), the patient had been off the pump.Further, the patient was released on (b)(6) 2022 or (b)(6) 2022 and then spent three weeks in the rehabilitation.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: 13926168
• MDR Text Key: 288022414
• Report Number: 3003442380-2022-00453
• 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: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 03/15/2022
• Patient Sequence Number: 1