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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 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 the united states. On (b)(6) 2021, it was reported by the patient;s mother that her daughter felt bad last night about 01:00 am, and today when she woke up, she started to throw up and she did not stop. So, she checked her blood glucose level and the meter kept saying she was low, due to which she was treated with soda and disconnected the pump, but she still felt bad. Consequently, she went to emergency room where it was found that her blood glucose level was over 600 mg/dl. Subsequently, on (b)(6) 2021 (on the same day), she was admitted to the hospital due to high blood glucose level, diabetic ketoacidosis and she was throwing up. During hospitalization, she was administered insulin drip intravenously. Further, it was observed that the cannula was bent, and the site location was her thigh. The infusion set had been used for the first day as it was changed on (b)(6) 2021 at 03:21 pm (about 12 hours). Currently, (at the time of this report) her blood glucose level was over 190 mg/dl and she was still in 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 NameMIO
Type of DeviceUNO INSET II 60/6 SC1 PINK MIMX
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key11918260
MDR Text Key253807376
Report Number3003442380-2021-00266
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 Received06/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/25/2021
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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