MAUDE Adverse Event Report: AUTOSOFT 90; UNO INSET II 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 that the patient faced a bent cannula which led to high blood glucose level therefore, they tried to treat it with bolus via pump, but on (b)(6) 2023, the patient went to the emergency room and was subsequently hospitalized due to severe diabetic ketoacidosis.Her highest blood glucose level was over 800 mg/dl.She had a heart attack and according to the patient, her kidneys "shut down".Moreover, the infusion set had been used for less than 72 hours.Further, she was transferred to the intensive care unit.During hospitalization, the patient received fluids of saline, insulin, antibiotics, unspecified (drug name unknown) medication and medication for her heart as corrective treatment which resolved the issue.On (b)(6) 2023, 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 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: 18472341
• MDR Text Key: 332376407
• Report Number: 3003442380-2024-00111
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244018129
• UDI-Public: 05705244018129
• Combination Product (y/n): Y
• 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: 01/08/2024

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: 01/02/2024
• Initial Date FDA Received: 01/08/2024
• Patient Sequence Number: 1