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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 (b)(6). It was reported that the patient experienced high blood glucose levels and diabetic ketoacidosis. Further, she attempted to manually inject (mainly bolus delivery of less than 3u) when she noticed she was going into diabetic ketoacidosis. The infusion set had been used for three days. Subsequently, on (b)(6) 2021, she went to the emergency room, with blood glucose level of more than 40 mmol/l which was due to a kinked cannula, where she was treated for her diabetic ketoacidosis (as she shad ketones) through insulin infusion, potassium and glucose while being admitted into hospital. She stayed in the emergency room for a few hours and left from there with blood glucose levels between 8 and 14 mmol/l. Consequently, on the same day ((b)(6) 2021), she was admitted to the hospital as she was still unwell. During hospitalization, she was administered insulin infusion, glucose and potassium as corrective treatment which resolved the issue. On (b)(6) 2021, she 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.
 
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Brand NameAUTOSOFT 90
Type of DeviceUNO INSET II 60/6 GREY TCAP 10PK INT
Manufacturer Contact
aaholmvej 1-3
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lejre, 4320
MDR Report Key12038718
MDR Text Key257451102
Report Number3003442380-2021-00293
Device Sequence Number1
Product Code FPA
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
0 Patients were Involved in the Event:
Date FDA Received06/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1002817
Device Lot Number5332940
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2021
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

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