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

MAUDE Adverse Event Report: AUTOSOFT 90 UNO INSET II 60/6 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 90 UNO INSET II 60/6 GREY TCAP 10PK INT Back to Search Results
Model Number 1002817
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) 2022, a (b)(6) female child patient faced a bent cannula symptoms/issue noticed after 3 hours after insertion. Therefore, her blood glucose level was 518 mg/dl at the time of this event which they tried to treat it with correction bolus via pump, multiple daily injection, and water consumption, but on the same day ((b)(6) 2022), the patient went to the emergency room due to high blood glucose level. Her highest blood glucose level was 518 mg/dl and she had ketone levels bordering between moderate and high ketones which her healthcare professional assessed as dangerous/life threatening. Moreover, the infusion set had been used for three days. During her stay in the emergency room, she received fluids of saline, insulin, and unspecified medication (drug name unknown) intravenously as corrective treatment which resolved the issue. After spending 12 hours in the emergency room, the next day ((b)(6) 2022), the patient was released with no permanent damage. Further, on (b)(6) 2022, the patient again faced a bent cannula symptoms/issue noticed after three hours after insertion. The infusion had been used for couple of hours. Moreover, 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 90
Type of DeviceUNO INSET II 60/6 GREY TCAP 10PK INT
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key14467759
MDR Text Key292356523
Report Number3003442380-2022-00678
Device Sequence Number1
Product Code FPA
UDI-Device Identifier05705244018129
UDI-Public05705244018129
Combination Product (y/n)Y
PMA/PMN Number
K032854
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation
Type of Report Initial
Report Date 05/23/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/23/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model Number1002817
Device Lot Number5359732
Was Device Available for Evaluation? No Answer Provided
Date Manufacturer Received05/12/2022
Was Device Evaluated by Manufacturer? No Answer Provided

-
-