• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AUTOSOFT XC UNO INSET I 60/9 GREY TCAP 10PK INT

  • 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
 

AUTOSOFT XC UNO INSET I 60/9 GREY TCAP 10PK INT Back to Search Results
Model Number 1001681
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. It was reported that on (b)(6) 2021, the patient faced kinked cannula symptoms/issue which were noticed within three hours of insertion. Moreover, the issue occurred with two cannulas in a row, which affected the insulin delivery. The patient's blood glucose level was 327 mg/dl at the time of the event, which she tried to treat with a correction bolus via pump. However, on an unknown date, the patient went to the emergency room and subsequently hospitalized due to high blood glucose level. Reportedly, she experienced some numbness in her feet. Moreover, she had moderate ketone levels and her highest blood glucose level was over 600 mg/dl. The patient was transferred to the intensive care unit, where she stayed for 4-5 days. Further, they replaced the infusion set and insulin was resumed successfully. 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 NameAUTOSOFT XC
Type of DeviceUNO INSET I 60/9 GREY TCAP 10PK INT
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key12524612
MDR Text Key273073137
Report Number3003442380-2021-00507
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
PMA/PMN Number
K032854
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
Report Date 09/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1001681
Device Lot Number5293407
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/16/2021
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

-
-