MAUDE Adverse Event Report: AUTOSOFT XC; INSET I 2-PACK 60/9 GREY TCAP

Lot Number 6000546

Device Problem Material Twisted/Bent (2981)

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 cannula within last week due to which he experienced high blood glucose level.Therefore, on (b)(6) 2024, the patient was admitted to the hospital due to high blood glucose level.Further, the patient was transferred to the intensive care unit.His highest blood glucose level was 1200 mg/dl.Moreover, the issue occurred with one infusion set used for three days and the site location was patient's abdomen.During hospitalization, the patient received fluids of saline, insulin, and unspecified medication (drug name unknown) intravenously as corrective treatment which resolved the issue.On (b)(6) 2024, the patient was released from the hospital with no permanent damage.Unomedical do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices of insertion sites and infusion sets and cannula length.Furthermore, the soft cannula is a flexible material that during use and upon removal can bend slightly.No further information was available.

• Brand Name: AUTOSOFT XC
• Type of Device: INSET I 2-PACK 60/9 GREY TCAP
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18893148
• MDR Text Key: 337519396
• Report Number: 3003442380-2024-00186
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244026032
• UDI-Public: 05705244026032
• Combination Product (y/n): N
• PMA/PMN Number: K032854
• 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: 03/13/2024

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: 6000546
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 03/13/2024
• Patient Sequence Number: 1