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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 5335776
Device Problem Material Deformation (2976)
Patient Problem Diabetic Ketoacidosis (2364)
Event Type  Injury  
Event Description
Unomedical reference number (b)(4). Event occurred in (b)(6). On (b)(6) 2021, it was reported that the patient's infusion set's tubing was kinked and saw some leaks in the midline. This issue occurred with six infusion sets from the same box. Therefore, due to this issue, on (b)(6) 2021, at 12:00 pm, the patient was admitted to the hospital due to diabetic ketoacidosis. During hospitalization, the patient received insulin drip and potassium as corrective treatment. On the next ((b)(6) 2021), at 04:30 pm, the patient was discharged from the hospital. The patient had been using the infusion set almost every day. Reportedly, there was no stress of pull on the infusion set tubing and the pump was not dropped with the set-in place. 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 Key12073756
MDR Text Key258635871
Report Number3003442380-2021-00298
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 Received06/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number5335776
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2021
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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