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 experienced high blood glucose level which he believes was due to a "bad' site insertion.Therefore, they called the ambulance and on (b)(6) 2022, the patient went to the to the emergency room due to high blood glucose level.His highest blood glucose level was over 800 mg/dl and he had high ketone levels which his healthcare professional assessed as dangerous/life threatening.Moreover, the infusion set had been used for 16 hours.Further, the patient was transferred to the intensive care unit.During hospitalization, he received fluids of saline, insulin, and unspecified medication (drug name unknown) intravenously as corrective treatment which resolved the issue.At the time of this report, the patient was still in the hospital and was not released but had no permanent damage.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: 14390112
• MDR Text Key: 291604019
• Report Number: 3003442380-2022-00658
• 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: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 05/03/2022
• Patient Sequence Number: 1