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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 Hyperglycemia (1905)
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 due to a kinked cannula. She attempted to manually inject (mainly bolus delivery of less than 3 units) when she noticed she was going into diabetic ketoacidosis. Subsequently, on (b)(6) 2021, the patient went to the emergency room, with blood glucose level of more than 30 mmol/l where she was treated with an unspecified medication (drug name unknown) intravenously and fluids. Her health care professional did not identify her ketone level as dangerous/life threatening. She stayed there only for a short period of time, as her blood glucose levels had decreased significantly (around 10 mmol/l) but was still feeling unwell so was consequently admitted into hospital. The infusion set had been used for one day. During hospitalization, she was administered unspecified medication (drug name unknown) intravenously and manual injections as per the instructions from her health care professional as corrective treatment which resolved the issue. She was released from the hospital on (b)(6) 2021 with no permanent damage. However, on (b)(6) 2021 she was again admitted to the hospital and was currently hospitalized. 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
osted
lejre, 4320
MDR Report Key12106022
MDR Text Key259637020
Report Number3003442380-2021-00306
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 Received07/02/2021
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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