MAUDE Adverse Event Report: AUTOSOFT 90; UNO INSET II 60/6 GREY TCAP 10PK INT

Lot Number 6002475

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 kinked cannula due to which he was not getting enough insulin.They tried to treat it by multiple daily injection.Therefore, on 15-jan-2024, she first went to the emergency room and was subsequently hospitalized.Further, the patient was transferred to the intensive care unit.The patient's highest blood glucose level was 500 mg/dl and had high ketone level which healthcare professional assessed as not dangerous or life-threatening.The infusion set was used for few hours.During hospitalization, the patient received fluids of saline (unknown), 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.Further, it was reported that over a month, the patient faced similar issue with 14 infusion sets, with site location as abdomen and blood glucose level of 500 mg/dl which they tried to treat with correction injection.The patient had high/large ketone level which the healthcare professional did not assess as dangerous/life threatening.The patient replaced infusion set and resumed insulin 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 60/6 GREY TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18950719
• MDR Text Key: 338254837
• Report Number: 3003442380-2024-00198
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244018129
• UDI-Public: 05705244018129
• 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

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: 6002475
• Date Manufacturer Received: 03/18/2024
• Patient Sequence Number: 1