MAUDE Adverse Event Report: AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT

Model Number 1001680

Device Problem Material Twisted/Bent (2981)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4). Event occurred in the united states. It was reported that the patient experienced high blood glucose level due to a bent cannula on the infusion set when they removed the cannula. Therefore, she tried to treat it with a bolus via the pump, but on (b)(6) 2021, the patient went to the emergency room and after staying for several hours in the emergency room, consequently the patient was hospitalized due to high blood glucose level. Her highest blood glucose level was 866 mg/dl and had high ketone level. Her healthcare professional told her to continue drinking fluids. Moreover, the infusion had been used for one day. During hospitalization, he received fluids of saline, insulin, injections of insulin and unspecified intravenous medication (drug name unknown) which resolved the issue. On (b)(6) 2021, the patient was released 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.

• Brand Name: AUTOSOFT XC
• Type of Device: UNO INSET I 60/6 GREY TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 12126438
• MDR Text Key: 260267826
• Report Number: 3003442380-2021-00318
• Device Sequence Number: 1
• Product Code: FPA
• 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

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 1001680
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No Answer Provided

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/29/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage