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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 a (b)(6) male child patient experienced high blood glucose level due to a bent cannula. Therefore, he tried to treat it was a bolus via pump, but subsequently, on (b)(6) 2021, the patient went to the emergency room due to high blood glucose level. His highest blood glucose level was above 700 mg/dl and had moderate ketone levels which the health care professional assessed not to be dangerous/life threatening. Moreover, the infusion set had been used for less than one day. While in the emergency room, he received fluids of saline, insulin, and unspecified intravenous medication (drug name unknown) as corrective treatment which resolved the issue. After staying for four hours in the emergency room, on the same day ((b)(6) 2021), the patient was released with no permanent damage. Moreover, it was also reported that patient's site ripped out while playing, one set had a bent cannula, insertion site was hard where needle was inserted and had a pus build up due to which he experienced high blood glucose level. Further, they removed the set and treated it with a correction bolus via pump. His highest blood glucose level was below 500 mg/dl and had moderate ketone level which the healthcare professional assessed not to be dangerous/life threatening. The patient did not notice any damage to the infusion sets when the package was first opened. They replaced the infusion set 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. 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 Key12082474
MDR Text Key258880585
Report Number3003442380-2021-00303
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 Received06/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1001680
Device Lot Number5338607
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2021
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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