MAUDE Adverse Event Report: INSET¿II; INSET II 60/6 BLUE

Lot Number	5201427
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hyperglycemia (1905)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in (b)(6).The patient reported that in one of his infusion sets, the tubing came away from the anchor at the clip part that had the needle due to which his blood glucose level reached 24 mmol/l without him realizing.This had occurred a few times while the patient was asleep in bed.No further information available.

• Brand Name: INSET¿II
• Common Device Name: INSET II 60/6 BLUE
• MDR Report Key: 8427498
• Report Number: 3003442380-2019-00609
• Device Sequence Number: 1147665
• Product Code: FPA
• UDI-Device Identifier: 05705244007413
• UDI-Public: 05705244007413
• Combination Product (Y/N): N
• PMA/510(K) Number: K032854
• 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 Expiration Date: 09/01/2020
• Device Lot Number: 5201427
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2018
• Initial Report FDA Received Date: 03/18/2019
• Patient Sequence Number: 1