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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIO; UNO INSET II 46/6 SC1 PINK MIMX

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MIO; UNO INSET II 46/6 SC1 PINK MIMX Back to Search Results
Lot Number 5360889
Device Problem Material Twisted/Bent (2981)
Patient Problem Diabetic Ketoacidosis (2364)
Event Type  Injury  
Event Description
Unomedical reference number (b)(4).Event occurred in (b)(6).On (b)(6) 2022, the patient's parent reported that their daughter had high blood glucose levels for three days now, due to a bent cannula which they tried to treat with a pump and manual injection.The infusion set was changed on (b)(6) 2022.At the time of the event ((b)(6) 2022), her blood glucose level was 20 mmol/l.Consequently, on (b)(6) 2022 at 1:00 am, she was admitted to the hospital as she experienced vomiting, abdominal pain, and positive results in ketones test (3 mmol/l).She was admitted in the hospital for three days.Currently, her blood glucose level was 26 mmol/l.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 Name
MIO
Type of Device
UNO INSET II 46/6 SC1 PINK MIMX
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key14332609
MDR Text Key291244631
Report Number3003442380-2022-00605
Device Sequence Number1
Product Code FPA
UDI-Device Identifier05705244019911
UDI-Public05705244019911
Combination Product (y/n)Y
PMA/PMN Number
K160648
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 05/09/2022
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 Date08/01/2024
Device Lot Number5360889
Initial Date Manufacturer Received 04/22/2022
Initial Date FDA Received05/08/2022
Patient Sequence Number1
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