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

Lot Number	5191502
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.It was reported that the patient changed his infusion set due to a kinked cannula and encountered high blood glucose level.He faced this issue with two infusion sets.Patient's blood glucose level at the time of this event was 500 mg/dl.The patient changed his infusion set site, administered correction boluses using the pump and multiple dose injections therapy by insulin pens, but it did not decrease.Subsequently, the patient went to the emergency room and continued pump therapy.The customer stated that due to his blood glucose level being high he could not recall if he was administering the correct correction amounts via the pump.Then he was taken to the intensive care unit and hospitalized.The patient received insulin via intravenous drip as corrective treatment, which made his blood glucose level stable and he was released with the use of the pump.The infusion set had been in use for one day.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 TCAP
• MDR Report Key: 8543359
• Report Number: 3003442380-2019-01151
• Device Sequence Number: 16236528
• Product Code: FPA
• UDI-Device Identifier: 05705244014305
• UDI-Public: 05705244014305
• 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: 5191502
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 04/24/2019
• Patient Sequence Number: 1