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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIO; UNO INSET II 60/6 SC1 BLUE MCAN
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MIO; UNO INSET II 60/6 SC1 BLUE MCAN Back to Search Results
Model Number MMT-943A600
Medical Device Problem Code Infusion or Flow Problem (2964)
Health Effect - Clinical Code Hyperglycemia (1905)
Type of Reportable Event Serious Injury
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in (b)(6).On (b)(6) 2022, the patient's mother reported that her daughter had some issues with her pump.Therefore, her pump kept alarming insulin flow blocked.They changed the reservoir and tubing, but the issue did not resolve.Reportedly, the issue occurred during bolus and basal.On the day of this report ( (b)(6) 2022), the patient received the insulin flow blocked alarm at 03:57 am and 04:15 am.Moreover, on (b)(6) 2022, she received the insulin flow blocked alarm at 10:50 pm, therefore, they changed the infusion set and reservoir at 10:57 pm and her blood glucose level was 25 mmol/l.Further, the patient's mother reported that the event was resolved by changing the complete set.Currently, her blood glucose level was 8.9 mmol/l.No further information available.
 
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Brand Name
MIO
Common Device Name
UNO INSET II 60/6 SC1 BLUE MCAN
Manufacturer Contact
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lejre, 4320
MDR Report Key13448530
Report Number3003442380-2022-00257
Device Sequence Number5247430
Product Code FPA
UDI-Device Identifier05705244020337
UDI-Public05705244020337
Combination Product (Y/N)Y
PMA/510(K) Number
K160648
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source Distributor
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 02/04/2022
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 Expiration Date01/01/2024
Device Model NumberMMT-943A600
Device Lot Number5346620
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/26/2022
Initial Report FDA Received Date02/04/2022
Patient Sequence Number1
Patient SexUnknown
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