Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIO; UNO INSET II 80/9 SC1 GREY MIMX
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MIO; UNO INSET II 80/9 SC1 GREY 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 that on one-night, the patient felt very sick after changing the infusion set and was vomiting.After the new set was in place, the patient stated that cannula was kinked at the end.Therefore, next morning on (b)(6) 2021 at 07:00 am, the patient went to the emergency room because he experienced high blood glucose level over 500 mg/dl.He did not take any manual injections and did not change the infusion set, the patient was admitted to the intensive care unit with blood glucose level over 800 mg/dl and diabetic ketoacidosis.He received insulin drip via intravenous route as corrective treatment.Reportedly, the patient was still hospitalized at the time of this report with blood glucose level of 125 mg/dl.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MIO
Type of Device
UNO INSET II 80/9 SC1 GREY MIMX
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key11956053
MDR Text Key254932099
Report Number3003442380-2021-00273
Device Sequence Number1
Product Code FPA
UDI-Device Identifier05705244020184
UDI-Public05705244020184
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
1 Patient was Involved in the Event
Date FDA Received06/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Lot NumberUNKNOWN
Date Manufacturer Received06/01/2021
Type of Device Usage N
Patient Sequence Number1
-
-