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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AUTOSOFT XC; UNO INSET I 110/6 GREY TCAP 10PK INT
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AUTOSOFT XC; UNO INSET I 110/6 GREY TCAP 10PK INT Back to Search Results
Lot Number UNKNOWN
Device Problem Infusion or Flow Problem (2964)
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 faced issues with infusion set tubing due to which insulin was not going through the line and she experienced high blood glucose level.Therefore, they tried to treat it with multiple daily injection, but on (b)(6) 2024, the patient first went to the emergency room and was subsequently hospitalized due to high blood glucose level.Her highest blood glucose level was 900 mg/dl and had high ketone level which the healthcare professional identified as dangerous or life-threatening.Moreover, the infusion had been used for three days.During hospitalization, the patient received fluids of saline, insulin, and unspecified medication (drug name unknown) intravenously as corrective treatment which resolved the issue.On (b)(6) 2024, the patient was released from the hospital with no permanent damage.No further information was available.
 
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Brand Name
AUTOSOFT XC
Type of Device
UNO INSET I 110/6 GREY TCAP 10PK INT
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key18577840
MDR Text Key333660877
Report Number3003442380-2024-00129
Device Sequence Number1
Product Code FPA
UDI-Device Identifier05705244016927
UDI-Public05705244016927
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 Other
Type of Report Initial
Report Date 01/25/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Lot NumberUNKNOWN
Initial Date Manufacturer Received 01/18/2024
Initial Date FDA Received01/25/2024
Patient Sequence Number1
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