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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 bent cannula issue with four infusion sets over the last two weeks. On (b)(6) 2021 (event date), the patient's blood glucose level was over 500 mg/dl, which the patient tried to treat via 15 units of humalog and 80 units of lantis (multiple daily injection). The infusion set had been used for one day and there was no damage to the infusion sets when the package was first opened. Consequently, on (b)(6) 2021, he was admitted to the intensive care unit with blood glucose level of more than 500 mg/dl. He had high ketones levels which the health care professional assessed as dangerous/ life threatening. During hospitalization, he was administered fluids of saline, insulin and an unknown medication intravenously (drug name unknown) as corrective treatment which resolved the issue. On (b)(6) 2021, the patient was released from the hospital 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
osted
lejre, 4320
MDR Report Key11869186
MDR Text Key252321996
Report Number3003442380-2021-00255
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 Received05/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1001680
Device Lot Number5320824
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/13/2021
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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