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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
Lot Number UNKNOWN
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 faced a kinked cannula with one infusion set due to which she experienced high blood glucose level.Therefore, they tried to treat it with multiple daily injection,but on (b)(6) 2023, she first went to the emergency room and was subsequently hospitalized due to high blood glucose level.Her highest blood glucose level was 600 mg/dl.Moreover, the infusion set was used for two days and the site location was patient's abdomen.During hospitalization, the patient received fluids of saline, insulin, and unspecified medication (drug name unknown) intravenously as corrective treatment which resolved the issue.On (b)(6) 2023, 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 was available.
 
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Brand Name
AUTOSOFT XC
Type of Device
UNO INSET I 60/6 GREY TCAP 10PK INT
Manufacturer Contact
aaholmvej 1-3
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lejre, 4320
MDR Report Key18683721
MDR Text Key335069805
Report Number3003442380-2024-00146
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
Reporter Occupation Other
Type of Report Initial
Report Date 02/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Lot NumberUNKNOWN
Date Manufacturer Received02/07/2024
Patient Sequence Number1
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