MAUDE Adverse Event Report: T:90¿ INFUSION SET; INSET II 60/9 PINK

Lot Number	UNKNOWN
Medical Device Problem Code	Infusion or Flow Problem (2964)
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 the united states.It was reported that insulin was not coming from the tubing line and the patient was hospitalized for diabetes ketoacidosis.Patient's blood glucose level was 626 mg/dl when she was admitted in the hospital.Prior to hospitalization, the patient tried delivering injections, boluses, and increasing the temperature rate on the pump but stated blood glucose level did not come down.During hospitalization, patient received insulin and fluids as corrective treatment which resolved the issue.The infusion had been in use for less than 2 days.The patient was hospitalized for five days.No further information available.

• Brand Name: T:90¿ INFUSION SET
• Common Device Name: INSET II 60/9 PINK
• MDR Report Key: 8564260
• Report Number: 3003442380-2019-01432
• Device Sequence Number: 14040677
• Product Code: FPA
• UDI-Device Identifier: 05705244004511
• UDI-Public: 05705244004511
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2017
• Initial Report FDA Received Date: 04/30/2019
• Patient Sequence Number: 1