MAUDE Adverse Event Report: AUTOSOFT 90¿; INSET II 60/6 GREY

Lot Number	UNKNOWN
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
(b)(4).Event occurred in the united states.It was reported that on (b)(6) 2019, the patient's blood glucose level was unresponsive to the pump insulin delivery.Furthermore, it was mentioned that his blood glucose level had been a bit harder to control and he also had a surgery recently.The patient experienced high blood glucose level, which he tried to treat by delivering boluses through pump and manual injections.On the same day, the patient was subsequently admitted to the hospital and highest blood glucose level reported was more than 600 mg/dl.The patient received lantus and shots as corrective treatment, which resolved the issue.The infusion set was used for one day and there was no permanent damage to the patient.At the time of this report, he was still in the hospital.After troubleshooting, it was found that the cannula was bent and was the cause of high blood glucose level.The patient was advised to put on all new supplies since the current ones were a week old.The patient did not notice any damage when the package was first opened.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 available.

• Brand Name: AUTOSOFT 90¿
• Common Device Name: INSET II 60/6 GREY
• MDR Report Key: 8858564
• Report Number: 3003442380-2019-01667
• Device Sequence Number: 13584590
• Product Code: FPA
• UDI-Device Identifier: 05705244014992
• UDI-Public: 05705244014992
• 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: 07/18/2019
• Initial Report FDA Received Date: 08/05/2019
• Patient Sequence Number: 1