MAUDE Adverse Event Report: AUTOSOFT 90; UNO INSET II 110/6 GREY TCAP 10PK INT

Lot Number UNKNOWN

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 a 06-years old male child patient faced a bent cannula due to which he experienced high blood glucose level.Therefore, they tried to treat it with insulin drip, but on (b)(6) 2023, he went to the emergency room and was subsequently admitted to the hospital due to high blood glucose level.His highest blood glucose level was 700 mg/dl and ketone level were high which the healthcare professional assessed as dangerous or life-threatening.Further, the patient was transferred to the intensive care unit.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) 2023, the patient was released from the hospital with no permanent damage.Moreover, this similar issue occurred on (b)(6) 2023 and (b)(6) 2024 with two similar types of infusion sets three or more hours after insertion.Moreover, the infusion had been used for two to three days and the site location was patient's abdomen.His blood glucose level at the time of event was 440-443 mg/dl.They replaced the infusion set and insulin was resumed successfully.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 90
• Type of Device: UNO INSET II 110/6 GREY TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18532573
• MDR Text Key: 333087274
• Report Number: 3003442380-2024-00121
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244018150
• UDI-Public: 05705244018150
• 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: 01/18/2024

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: UNKNOWN
• Initial Date Manufacturer Received: 01/12/2024
• Initial Date FDA Received: 01/18/2024
• Patient Sequence Number: 1