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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AUTOSOFT 90; UNO INSET II 60/6 GREY TCAP 10PK INT
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AUTOSOFT 90; UNO INSET II 60/6 GREY TCAP 10PK INT Back to Search Results
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 the united states.It was reported that a patient experienced high blood glucose levels and diabetic ketoacidosis due to a bent cannula after more than three hours of insertion and they tried to treat it with a bolus via the pump.The infusion set had been used for one day.Consequently, on (b)(6) 2021, she was admitted to the emergency room with blood glucose level of 493 mg/dl and high ketones.She was administered multiple daily injections and fluids of saline and insulin intravenously as corrective treatment which resolved the issue.Moreover, she stayed in the emergency room for twelve hours, was discharged on (b)(6) 2021 and had no permanent damage.Reportedly, since her discharge, she successfully replaced the infusion set and resumed insulin delivery.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.
 
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Brand Name
AUTOSOFT 90
Type of Device
UNO INSET II 60/6 GREY TCAP 10PK INT
MDR Report Key12363923
MDR Text Key268038029
Report Number3003442380-2021-00392
Device Sequence Number1
Product Code FPA
UDI-Device Identifier05705244018129
UDI-Public05705244018129
Combination Product (y/n)Y
PMA/PMN Number
K032854
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date02/01/2024
Device Model Number1002817
Device Lot Number5345501
Date Manufacturer Received08/06/2021
Type of Device Usage N
Patient Sequence Number1
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