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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 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 (484 mg/dl). Therefore, she tried to treat it with a bolus via pump (self-administered 3 units with 4 units of insulin on board). On (b)(6) 2021, the patient went to the emergency room due to diabetic ketoacidosis with blood glucose level of 484 mg/dl. While in the emergency room, the healthcare profession was checking her and noticed that the cannula was bent due to which she experienced high blood glucose level. She changed her infusion set on the same day of hospitalization ((b)(6) 2021). After staying for two days in the emergency room, she was admitted to the intensive care unit, where she received fluids of saline, insulin, pain medication and anxiety medication on the night of (b)(6) 2021 as corrective treatment, which resolved the issue. Currently, the patient was still admitted in the hospital with no permanent damage to her. Moreover, she experienced this issue with four of her infusion sets. Further, the patient did not notice any damage to the infusion sets when the package was first opened. 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 XC
Type of DeviceUNO INSET I 60/6 GREY TCAP 10PK INT
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key11789556
MDR Text Key249442162
Report Number3003442380-2021-00241
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 Received05/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1001680
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/29/2021
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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