MAUDE Adverse Event Report: I PORT ADVANCE; I-PORT ADVANCE 6 MM

Model Number MMT-100

Device Problem Material Twisted/Bent (2981)

Patient Problem Hyperglycemia (1905)

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4).Event occurred in canada on (b)(6) 2023, the patient's mother reported that her son experienced some issues with the infusion sets as first 04 infusion set from the first box did not work and she opened the second box, but she had the same issue with the infusion sets as well.Moreover, the patient's blood glucose level went up to 27 mmol/l and he experienced diabetic ketoacidosis as they tested for ketone level which was high.Further, the mother stated that the infusion set's cannula was bent and the infusion set had been used for a few hours.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: I PORT ADVANCE
• Type of Device: I-PORT ADVANCE 6 MM
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 16441419
• MDR Text Key: 310341453
• Report Number: 3003442380-2023-00182
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 05705244009394
• UDI-Public: 05705244009394
• Combination Product (y/n): Y
• PMA/PMN Number: K120337
• 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: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MMT-100
• Device Lot Number: 5388418
• Date Manufacturer Received: 02/14/2023
• Patient Sequence Number: 1