MAUDE Adverse Event Report: AUTOSOFT¿ XC; UNO INSET I 60/6 GREY TCAP 10PK INT

Model Number 1001680

Device Problem Material Twisted/Bent (2981)

Patient Problems Bacterial Infection (1735); Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.The patient's mother reported that her (b)(6) son faced a kinked cannula at the muscle causing site rejection and subsequent staph infection which led to high blood glucose level.Therefore, they tried to treat it by changing out the site.On (b)(6) 2021, the patient first went to the emergency room and subsequently, he was admitted to the intensive care unit.The patient's highest blood glucose level was 597 mg/dl and had moderate ketone levels which his healthcare professional assessed as dangerous/life threatening.The infusion had been used for two days.During hospitalization, he received fluids of saline, insulin, and unspecified medication (drug name unknown) intravenously as corrective treatment which resolved the issue.On (b)(6) 2021, 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¿ XC
• Type of Device: UNO INSET I 60/6 GREY TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 13024117
• MDR Text Key: 282378732
• Report Number: 3003442380-2021-00820
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244016620
• UDI-Public: 05705244016620
• 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: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1001680
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 12/09/2021
• Patient Sequence Number: 1