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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIO; UNO INSET II 60/6 SC1 PINK MIMX
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MIO; UNO INSET II 60/6 SC1 PINK MIMX Back to Search Results
Lot Number 5385810
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.On (b)(6) 2023, it was reported that the patient faced a bent cannula when she removed the infusion sets.Due to this issue she felt sick, very weak, her bile threw up and experienced high blood glucose level.Therefore, they tried to treat it via pump, but her blood glucose level was not coming down.So, on (b)(6) 2023, she was admitted to the hospital due to diabetic ketoacidosis with blood glucose level of 500 mg/dl.During hospitalization, the patient received insulin drip intravenously as corrective treatment.After staying for three days in the hospital, the patient was released.Currently, her blood glucose level was 114 mg/dl.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
MIO
Type of Device
UNO INSET II 60/6 SC1 PINK MIMX
Manufacturer Contact
aaholmvej 1-3
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lejre, 4320
MDR Report Key18433836
MDR Text Key331781556
Report Number3003442380-2024-00105
Device Sequence Number1
Product Code FPA
UDI-Device Identifier05705244019942
UDI-Public05705244019942
Combination Product (y/n)N
PMA/PMN Number
K160648
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 01/03/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Lot Number5385810
Initial Date Manufacturer Received 12/23/2023
Initial Date FDA Received01/03/2024
Patient Sequence Number1
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