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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AUTOSOFT 90 UNO INSET II 60/6 BLUE TCAP 10PK INT

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AUTOSOFT 90 UNO INSET II 60/6 BLUE TCAP 10PK INT Back to Search Results
Model Number 1002823
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 a (b)(6) year-old male child patient experienced high blood glucose level due to a kinked cannula. Therefore, they tried to treat it with multiple daily injections, but on (b)(6) 2022, the patient went to the emergency room due to high blood glucose level. His highest blood glucose level was between 600-700 mg/dl, and he had high ketone levels which his healthcare professional assessed as dangerous/life threatening. Moreover, the infusion set had been used for 3 days. After spending four hours in the emergency room, the patient was transferred to the intensive care unit. During hospitalization, he received fluids of saline, insulin, and unspecified medication (drug name unknown) intravenously as corrective treatment which resolved the issue. On (b)(6) 2022, the patient was released from the hospital with no permanent damage. 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 NameAUTOSOFT 90
Type of DeviceUNO INSET II 60/6 BLUE TCAP 10PK INT
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key14390040
MDR Text Key291600797
Report Number3003442380-2022-00657
Device Sequence Number1
Product Code FPA
UDI-Device Identifier05705244018303
UDI-Public05705244018303
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 05/13/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/13/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model Number1002823
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Date Manufacturer Received05/03/2022
Was Device Evaluated by Manufacturer? No Answer Provided

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