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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 Defective Device (2588)
Patient Problem Diabetic Ketoacidosis (2364)
Event Type  Injury  
Event Description
Unomedical reference number (b)(4).Event occurred in (b)(6).It was reported that a 15-year-old male child patient faced an issue with the cannula as the tip remained part was missing, and it looked as if it was melted.Due to this issue, he experienced high blood glucose level.Therefore, they tried to treat it with bolus via pump, but on (b)(6) 2022, the patient was admitted to the hospital due to high blood glucose level.His highest blood glucose level was in 600s mg/dl and had high ketone level which his healthcare professional assessed as dangerous/life threatening.Moreover, the infusion had been used for half a day.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) 2022, the patient was released from the hospital with no permanent damage.No further information available.
 
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Brand Name
AUTOSOFT XC
Type of Device
UNO INSET I 60/6 GREY TCAP 10PK INT
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key16441461
MDR Text Key310226805
Report Number3003442380-2023-00185
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 Other
Type of Report Initial
Report Date 02/27/2023
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 Model Number1001680
Device Lot Number5405920
Initial Date Manufacturer Received 02/16/2023
Initial Date FDA Received02/26/2023
Patient Sequence Number1
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