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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRUSTEEL; UNO CONTACT DETACH G29 60/6TCAP 10PK INT
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TRUSTEEL; UNO CONTACT DETACH G29 60/6TCAP 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 17-years-old male child patient faced an occlusion alarm due to which he experienced high blood glucose level.Therefore, they tried to treat it with bolus via pump and drank lots of water but on (b)(6) 2024, the patient first went to emergency room and was subsequently hospitalized due to high blood glucose level.His blood glucose level due to the issue was 549 mg/dl and had moderate ketone level which healthcare professional did not assess as dangerous or life-threatening.Moreover, the infusion had been used for one 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) 2024, the patient was released from the hospital with no permanent damage.No further information was available.
 
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Brand Name
TRUSTEEL
Type of Device
UNO CONTACT DETACH G29 60/6TCAP 10PK INT
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key19039504
MDR Text Key339320936
Report Number3003442380-2024-00214
Device Sequence Number1
Product Code FPA
UDI-Device Identifier05705244018426
UDI-Public05705244018426
Combination Product (y/n)N
PMA/PMN Number
K041545
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 04/04/2024
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 04/02/2024
Initial Date FDA Received04/04/2024
Patient Sequence Number1
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