MAUDE Adverse Event Report: AUTOSOFT 90; UNO INSET II 60/6 GREY TCAP 10PK INT

Model Number 1002817

Device Problem Material Twisted/Bent (2981)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in (b)(6).It was reported that on (b)(6) 2021 (at 8:00 am), the patient changed cartridge and infusion set, but the patient's blood glucose level was rising, so injected a correction bolus at 6:00 pm (on the same day).However, on (b)(6) 2021 (at 5:00 am), the patient did not feel well during the night as the blood glucose level was over 511 mg/dl and had ketones because of a kinked cannula.Therefore, the patient immediately called the health care professional and went to the hospital.Reportedly, the healthcare professional assessed the ketone level as dangerous/life threatening.However, on (b)(6) 2021 (the same day), the patient was admitted to the hospital where infusion and kalium was administered as corrective treatment which resolved the issue.On (b)(6) 2021, the patient was released from the hospital with no permanent damage.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.

Event Description

Previously, the report was submitted on 06-sep-2021.However, it was identified as duplicate of report submitted with mfr number - 3003442380-2021-00435.

• Brand Name: AUTOSOFT 90
• Type of Device: UNO INSET II 60/6 GREY TCAP 10PK INT
• MDR Report Key: 12426931
• MDR Text Key: 270291509
• Report Number: 3003442380-2021-00427
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244018129
• UDI-Public: 05705244018129
• Combination Product (y/n): Y
• PMA/PMN Number: K032854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/01/2023
• Device Model Number: 1002817
• Device Lot Number: 5338491
• Date Manufacturer Received: 08/17/2021
• Type of Device Usage: N
• Patient Sequence Number: 1