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

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
Unomedical reference number (b)(4).Event occurred in the united states.The patient faced bent cannula issues due to which the patient experienced diabetic ketoacidosis and high blood glucose level reported to be 268 mg/dl, at the time of event.The patient tried to treat it with a bolus and basal rate was changed to 1.2 units.The patient arrived at the emergency room with blood glucose level at 800 mg/dl and stayed there for one day.The patient's level of ketones was assesed as dangerous/life threatening by a healthcare professional.Subsequently, the patient left the emergency room with blood glucose level at 800 mg/dl and was hospitalized.The patient was still in diabetic ketoacidosis and was unconscious.The patient received saline and insulin drip as corrective treatment, which resolved the issue.The infusion set had been in use for one day.There was no permanent damage to the patient and the patient did not notice any damage when the package was first opened.The patient had been in the hospital for five days and was still there at the time of this report.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 110/6 GREY TCAP
• MDR Report Key: 8598111
• Report Number: 3003442380-2019-01467
• Device Sequence Number: 2074823
• 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 Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2019
• Initial Report FDA Received Date: 05/10/2019
• Patient Sequence Number: 1