MAUDE Adverse Event Report: MIO¿; INSET II 80/6 PCC PINK

Lot Number	5141470
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Type of Reportable Event	Serious Injury
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.The patient reported issues with three infusion sets in the form of bent cannulas.She woke up and her blood glucose was 132 mg/dl, went through her normal routine and took her set off and showered.As she changed her set, it was noticed that the cannula was folded over on itself.She put on a new set and by the time of breakfast her blood glucose level was elevated to 287 mg/dl.She self-treated with the bolus by the pump and gave herself an injection with a syringe.She stated throughout the day her blood glucose levels continued to elevate.She had vomiting, her blood glucose was in the range of 400 mg/dl and experienced diabetic ketoacidosis.She was taken to the emergency room and was subsequently admitted, after some investigations.When the set was removed, after being admitted, she noticed the bent cannula.She ended up in the hospital with the last bent cannula.During hospitalization, she was on insulin drip.The location was left lower side of stomach.The infusion set was used for the first day.Currently, her blood glucose was 132 mg/dl and she was admitted for three days.Earlier at the time of first event, she inserted the set but later noticed that it hanged loose.At the time of second event, the cannula was bent, and the set never penetrated her body.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: MIO¿
• Common Device Name: INSET II 80/6 PCC PINK
• MDR Report Key: 8517260
• Report Number: 3003442380-2019-01241
• Device Sequence Number: 1846416
• Product Code: FPA
• UDI-Device Identifier: 05705244007871
• UDI-Public: 05705244007871
• Combination Product (Y/N): N
• PMA/510(K) Number: K160648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial

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
• Operator of Device: No Information
• Device Lot Number: 5141470
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2016
• Initial Report FDA Received Date: 04/16/2019
• Patient Sequence Number: 1