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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIO UNO INSET II 60/6 SC1 BLUE MIMX

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MIO UNO INSET II 60/6 SC1 BLUE MIMX Back to Search Results
Lot Number 5352400
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Diabetic Ketoacidosis (2364)
Event Type  Injury  
Event Description
Unomedical reference number (b)(4). Event occurred in the united states. On (b)(6) 2021, it was reported that the patient experienced confusion, feeling sick, unwell, altered vision and her highest blood glucose level was 675 mg/dl. Further, it is stated that her infusion sets were leaking. Consequently, she was admitted to the hospital on (b)(6) 2021 at 4:00 pm with blood glucose level of 670 mg/dl. Moreover, the patient was still in the hospital at the time of this report. No further information available.
 
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Brand NameMIO
Type of DeviceUNO INSET II 60/6 SC1 BLUE MIMX
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key12363883
MDR Text Key268036625
Report Number3003442380-2021-00389
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
PMA/PMN Number
K160648
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 Received08/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number5352400
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/02/2021
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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