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

Lot Number	UNKNOWN
Medical Device Problem Code	Detachment of Device or Device Component (2907)
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 infusion set tubing came apart while sleeping.The site location was at left side of the abdomen.The location of detachment was at site.The infusion was being used for 2 days.Reportedly, the pump was laying on the patient's side.The infusions were not stored or used, in a place where they might have been exposed to extreme temperatures and humidity.The patient was not sure whether there was any stress or pull on the tubing, however, the pump was not dropped with the set connected to the patient's body.The patient also stated her blood glucose was high due to this detachment.No further information available.

• Brand Name: MIO¿
• Common Device Name: INSET II 80/6 PCC PINK
• MDR Report Key: 8247437
• Report Number: 3003442380-2019-00190
• Device Sequence Number: 1439882
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 01/15/2019
• Patient Sequence Number: 1