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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIO¿ INSET II 60/6 PCC BLUE

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MIO¿ INSET II 60/6 PCC BLUE Back to Search Results
Lot Number 5243226
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. The patient had issues with the infusion set which led to high blood glucose (over 500 mg/dl). She felt like she had flu and was not able to bring down the raised blood glucose although she kept trying to treat. Reportedly, she did not feel well, so went to bed but had no fever. Subsequently, she was diagnosed for diabetic ketoacidosis and was hospitalized for several days. She received insulin drip as a corrective treatment. No further information available.
 
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Brand NameMIO¿
Type of DeviceINSET II 60/6 PCC BLUE
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key8360772
MDR Text Key136846175
Report Number3003442380-2019-00510
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
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 Received02/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/01/2021
Device Lot Number5243226
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/20/2018
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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