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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT

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AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT Back to Search Results
Model Number 1001680
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 the patient experienced high blood glucose level due to a bent cannula and a bad site with the infusion. Therefore, they tried to treat it with by changing the infusion set and drank water, but on (b)(6) 2022, the patient was admitted to the hospital due to high blood glucose level. Her highest blood glucose level was above 600 mg/dl and she had traces of ketone levels which her healthcare professional did not assessed as dangerous/life threatening. Moreover, the infusion set had been used for one day. Further, the patient was transferred to the intensive care unit. During hospitalization, she 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 XC
Type of DeviceUNO INSET I 60/6 GREY TCAP 10PK INT
Manufacturer Contact
aaholmvej 1-3
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lejre, 4320
MDR Report Key14467638
MDR Text Key292357082
Report Number3003442380-2022-00675
Device Sequence Number1
Product Code FPA
UDI-Device Identifier05705244016620
UDI-Public05705244016620
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 05/19/2022
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 Number1001680
Device Lot Number5353185
Was Device Available for Evaluation? No Answer Provided
Date Manufacturer Received05/12/2022
Was Device Evaluated by Manufacturer? No Answer Provided

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