MAUDE Adverse Event Report: AUTOSOFT 90; INSET II 110/6 GREY TCAP

Lot Number	5257651
Medical Device Problem Code	Material Twisted/Bent (2981)
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.The patient reported that she changed her supplies at night and the next day, she woke up with high blood glucose level.She tried to give herself a bolus through her pump, but it did not go through due to a bent cannula.Subsequently, she went to the emergency room with diabetic ketoacidosis and blood glucose level was at 470 mg/dl upon arrival.Her level of ketones was identified to be dangerous/ life threatening by a healthcare professional.In the emergency room, her blood tests were performed, and she was given insulin through intravenous drip.She stayed there for a couple of hours and thereafter, she was admitted to the hospital on (b)(6) 2019.As corrective treatment, she received insulin and fluids via intravenous drips in the hospital, which resolved the issue.Additionally, her blood tests were performed.The infusion set had been in use for less than a day.The patient was released from the hospital on (b)(6) 2019.There was no permanent damage to the patient.Unomedical do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices of insertion sites and infusion sets and cannula length.Furthermore, the soft cannula is a flexible material that during use and upon removal can bend slightly.No further information was available.

• Brand Name: AUTOSOFT 90
• Common Device Name: INSET II 110/6 GREY TCAP
• MDR Report Key: 8762231
• Report Number: 3003442380-2019-01601
• Device Sequence Number: 2637522
• Product Code: FPA
• UDI-Device Identifier: 05705244014336
• UDI-Public: 05705244014336
• 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 Expiration Date: 10/01/2021
• Device Lot Number: 5257651
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 07/04/2019
• Patient Sequence Number: 1