MAUDE Adverse Event Report: AUTOSOFT XC; UNO INSET I 60/6 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 by patient's mother that her 16-year-old son faced a bent cannula due to which he experienced high blood glucose level.Therefore, they tried to treat it with correction injection via multiple daily injection, but on (b)(6) 2023, the mother drove her son to the emergency room, and he was subsequently hospitalized due to high blood glucose level.Further, the patient was transferred to the intensive care unit.His highest blood glucose level ranged between 580-600 mg/dl.He had moderate ketone level which the healthcare professional assessed as dangerous or life-threatening.Also, the infusion set was used for four hours, and site location was abdomen.During hospitalization, the patient received fluids of saline, insulin, and unspecified medication (drug name unknown) intravenously as corrective treatment.After staying for three days in hospital, the patient was released from the hospital on (b)(6) 2023 with no permanent damage.Moreover, this similar issue occurred on (b)(6) 2024 with one infusion set and the site location was patient's abdomen.Furthermore, the blood glucose level of the patient at the time of event was 460 mg/dl.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: UNO INSET I 60/6 GREY TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18950386
• MDR Text Key: 338252075
• Report Number: 3003442380-2024-00195
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244016620
• UDI-Public: 05705244016620
• 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: 03/21/2024

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: 03/14/2024
• Initial Date FDA Received: 03/21/2024
• Patient Sequence Number: 1