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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 on (b)(6) 2021, a (b)(6)-year-old male patient experienced high blood glucose level of 356 mg/dl due to a kinked cannula. To treat this issue, a multiple daily injection was administered. The infusion set had been used for approximate 3-4 hours. Consequently, (on the same day) he was taken to the emergency room, as he experienced high blood glucose level of 356 mg/dl and high ketones which were not assessed as dangerous/life threatening by the healthcare professional. During his stay, he was administered fluids of saline, insulin, and an unknown medication intravenously (drug name unknown) as corrective treatment which resolved the issue. Moreover, after six hours of stay in the emergency room he was released on the same day (b)(6) 2021 with no permanent damage. Reportedly, the infusion set was replaced, and insulin was resumed 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 60/6 GREY TCAP 10PK INT
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key12489555
MDR Text Key271958862
Report Number3003442380-2021-00484
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 Received09/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1001680
Device Lot Number5345413
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/09/2021
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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