MAUDE Adverse Event Report: AUTOSOFT 90; INSET II 60/6 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 experienced high blood glucose level resulting in diabetic ketoacidosis as she was unaware that the pump had stopped administering insulin.She self-treated it with an insulin injection.Subsequently, she was admitted to the emergency room and upon arrival, patient's blood glucose level was more than 600 mg/dl and level of ketones was identified as dangerous/life threatening by a healthcare profession.The patient was administered with insulin via syringe and metoprolol to treat heart rhythm irregularities directly related to diabetic ketoacidosis, which resolved the issue.The patient stayed in the emergency room for eight hours.When she left the emergency room, her condition was stable but was hospitalized for observation.Upon removal of her cannula, she noticed that it was bent.The infusion set had been in use for approximately 24 hours.The patient stayed in the hospital for three days.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: 8535016
• Report Number: 3003442380-2019-01210
• Device Sequence Number: 10840784
• 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: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2018
• Initial Report FDA Received Date: 04/22/2019
• Patient Sequence Number: 1