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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 (b)(6). It was reported that a (b)(6) female child patient experienced high blood glucose level due to a kinked cannula on the infusion site. Therefore, she tried to treat it with multiple daily injection and changed the site, but the second site was also kinked, it turned out. Subsequently, on (b)(6) 2021, the patient went to the emergency room due to high blood glucose level. Her highest blood glucose level was 520 mg/dl and had moderate ketone levels which the health care professional assessed not to be dangerous/life threatening. Moreover, the infusion was changed the same day when the patient was admitted to the emergency room. While in the emergency room, she received fluids of saline, insulin, and unspecified intravenous medication (drug name unknown) as corrective treatment which resolved the issue. After staying for three hours in the emergency room, on the same day ((b)(6) 2021), the patient was released with no permanent damage. 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
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lejre, 4320
MDR Report Key12073795
MDR Text Key258627730
Report Number3003442380-2021-00300
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 Received06/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1001680
Device Lot Number5338628
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2021
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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