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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AUTOSOFT XC UNO INSET I 80/6 GREY TCAP 10PACK US

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AUTOSOFT XC UNO INSET I 80/6 GREY TCAP 10PACK US Back to Search Results
Model Number 1003912
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 a (b)(6)-year old male child patient experienced high blood glucose levels due to a bent cannula. At the time of the event, his blood glucose level was 574 mg/dl which he tried to treat with a correction bolus via the pump. Subsequently, on (b)(6) 2021, he was admitted to the emergency room, was then transferred to pediatric intensive care unit in ambulance and was consequently hospitalized. He had high ketones, which his health care professional assessed as dangerous/ life threatening. During his stay, he was administered fluids of saline, insulin and intravenously some unspecified medication (drug name unknown) as corrective treatment which resolved the issue. On (b)(6) 2021, he was released from the hospital with no permanent damage. This issue occurred with one infusion set and it was used a little more than 12 hours. Further, there was no damage to the infusion sets when the package was first opened. Reportedly, they replaced the infusion set and resumed insulin successfully. 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 80/6 GREY TCAP 10PACK US
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key12126426
MDR Text Key260226349
Report Number3003442380-2021-00313
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 Received07/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1003912
Device Lot Number5320812
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/29/2021
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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