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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AUTOSOFT 90 UNO INSET II 60/9 GREY TCAP 10PK INT

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AUTOSOFT 90 UNO INSET II 60/9 GREY TCAP 10PK INT Back to Search Results
Model Number 1002819
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 and her left arm was a little shaky. This event occurred due to a kinked cannula which the patient noticed when she went to the bed. The patient became unconscious and on (b)(6) 2021, she was hospitalized due to high blood glucose level. Subsequently, the patient was transferred to the intensive care unit. Her highest blood glucose level was over 1000 mg/dl and the infusion set had been used for one day. She could not recall the treatment she received at the hospital to help her blood glucose level lower down because she was unconscious for twelve days in the intensive care unit, but the issue was resolved with no permanent damage caused to the patient and she was released from the hospital on (b)(6) 2021. 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 60/9 GREY TCAP 10PK INT
Manufacturer Contact
aaholmvej 1-3
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lejre, 4320
MDR Report Key12553516
MDR Text Key273990599
Report Number3003442380-2021-00519
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
Report Date 09/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1002819
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2021
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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