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U.S. Department of Health and Human Services

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

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AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT Back to Search Results
Model Number 1001680
Device Problem Appropriate Term/Code Not Available (3191)
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 of 700 mg/dl and high ketones due to an issue with the infusion set but she did not notice any visual defect. There was no damage to the infusion sets when the package was first opened. Moreover, she was not able to get insulin from her infusion set, so she removed her set and replaced it. She tried to treat the issue with a bolus via the pump and her infusion set had been used for one day. Consequently, the patient was admitted to the emergency room, where she was administered insulin drip, potassium intravenously and saline fluid. Further, the health care professional did not assess the ketone level dangerous or life threatening. Her blood glucose level was between 110-150 mg/dl, when she left the emergency room, but her condition was unstable. Subsequently, on (b)(6) 2020 she was admitted to the hospital and was administered insulin drip, potassium intravenously and saline fluid as corrective treatment which resolved the issue. On (b)(6) 2020, she was released from the hospital with no permanent damage. Reportedly, she replaced the infusion set and insulin was resumed successfully. No further information available.
 
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Brand NameAUTOSOFT XC
Type of DeviceUNO INSET I 60/6 GREY TCAP 10PK INT
Manufacturer Contact
aaholmvej 1-3
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lejre, 4320
MDR Report Key11363872
MDR Text Key233127898
Report Number3003442380-2021-00155
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 Received02/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1001680
Device Lot Number5320812
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/08/2021
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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