MAUDE Adverse Event Report: MIO¿; INSET II 46/6 PCC BLUE

Model Number	MMT-941600
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 (b)(6).The patient's mother reported that her son experienced nausea, vomiting and high blood glucose level (33.3 mmol/l) as the patient's site was changed the night before and the cannula was not in the body.Therefore, the patient was admitted to the emergency room and subsequently, in the morning of (b)(6) 2020 at 06:30 am with blood glucose level of 33.3 mmol/l.Moreover, patient had ketones.Further, they removed the cannula at the hospital and found that the cannula was bent, but not in him.The cannula was inserted on butt and he did not feel any leaks.Patient's mother stated that one infusion set they inserted after the hospital, was also bent, the third one was causing blood glucose level to raise but she continued to bolus.Patient's mother removed it on the second day, and it was slightly bent.They had been using solely his upper buttocks for insertion, but due to the incident, patient's mother agreed to use alternate sites for the foreseeable future.Although, patient's blood glucose level remained higher than normal for several days.During hospitalization, he received insulin and intravenous medication (drug name unknown).The patient was released on sunday afternoon.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 46/6 PCC BLUE
• MDR Report Key: 9961705
• Report Number: 3003442380-2020-00243
• Device Sequence Number: 741914
• Product Code: FPA
• UDI-Device Identifier: 05705244007338
• UDI-Public: 05705244007338
• 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 Expiration Date: 03/01/2022
• Device Model Number: MMT-941600
• Device Lot Number: 5277346
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 04/15/2020
• Patient Sequence Number: 1