MAUDE Adverse Event Report: MIO¿; INSET II 60/6 PCC PINK

Lot Number	5278135
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 reported that while sleeping in the middle of night, the infusion set's tubing got ripped out at the quick release and the infusion set was no longer connected to her body.The site of location was her left thigh and the pump was worn on the waist band.The infusion had been in use for two days and they were stored at room temperature.There was stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.No further information available.
Event or Problem Description
On 28-nov-2019: follow up information was submitted because result of complaint investigation of the returned used device (1 set) showed that all the test result was within specifications.Based on the result: device, method, result and conclusion codes were updated.Unomedical reference number (b)(4).Event occurred in the united states.The patient reported that while sleeping in the middle of night, the infusion set's tubing got ripped out at the quick release and the infusion set was no longer connected to her body.The site of location was her left thigh and the pump was worn on the waist band.The infusion had been in use for two days and they were stored at room temperature.There was stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.No further information available.

• Brand Name: MIO¿
• Common Device Name: INSET II 60/6 PCC PINK
• MDR Report Key: 8958871
• Report Number: 3003442380-2019-01785
• Device Sequence Number: 2562736
• Product Code: FPA
• UDI-Device Identifier: 05705244007697
• UDI-Public: 05705244007697
• 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: 04/01/2022
• Device Lot Number: 5278135
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 08/20/2019
• Initial Report FDA Received Date: 09/04/2019
• Supplement Report FDA Received Date: 11/28/2019
• Patient Sequence Number: 1