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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AUTOSOFT 90; UNO INSET II 60/6 GREY TCAP 10PK INT
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AUTOSOFT 90; UNO INSET II 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 canada.It was reported that the patient faced a kinked cannula, and she experienced high blood glucose level.Therefore, she tried to treat it with bolus via pump, but on (b)(6) 2024, the patient first went to the emergency room and was subsequently hospitalized due to high blood glucose of 32 mmol/l.Moreover, the infusion had been used for few hours.During hospitalization, the patient received fluids of saline, insulin, and unspecified medication (drug name unknown) as corrective treatment which resolved the issue.On (b)(6) 2024, the patient was discharged from the hospital.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 Name
AUTOSOFT 90
Type of Device
UNO INSET II 60/6 GREY TCAP 10PK INT
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key18892726
MDR Text Key337511424
Report Number3003442380-2024-00189
Device Sequence Number1
Product Code FPA
UDI-Device Identifier05705244018129
UDI-Public05705244018129
Combination Product (y/n)N
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 03/13/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Lot NumberUNKNOWN
Date Manufacturer Received03/08/2024
Patient Sequence Number1
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