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

Model Number	MMT-925
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.The patient's son reported that the patient had five sets where the tubing detached close to the site location and would just be hanging while the patient was either walking, sitting or sleeping.She had a bad knee, so she did not engage in strenuous activities.The site location was either left or right hip and the pump was either on the left, right or same side as the infusion set in the bra or pocket.This happened usually on the first or second day of use.The infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.There was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.No further information available.
Event or Problem Description
On 04-feb-2020: follow up information was submitted because result of complaint investigation of the returned used devices (5 used sets) showed that all test results were within specifications based on the result: device, method, result and conclusion codes were updated.Unomedical reference number (b)(4).Event occurred in (b)(6).The patient's son reported that the patient had five sets where the tubing detached close to the site location and would just be hanging while the patient was either walking, sitting or sleeping.She had a bad knee, so she did not engage in strenuous activities.The site location was either left or right hip and the pump was either on the left, right or same side as the infusion set in the bra or pocket.This happened usually on the first or second day of use.The infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.There was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.No further information available.

• Brand Name: MIO¿
• Common Device Name: INSET II 80/6 PCC PINK
• MDR Report Key: 8576672
• Report Number: 3003442380-2019-01454
• Device Sequence Number: 14039883
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 11/01/2021
• Device Model Number: MMT-925
• Device Lot Number: 5260658
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2019
• Supplement Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 05/03/2019
• Supplement Report FDA Received Date: 02/04/2020
• Patient Sequence Number: 1