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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
Model Number 1002833
Device Problem Loss of or Failure to Bond (1068)
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 an issue with the infusion set as her infusion set fell off during use and the patient experienced high blood glucose level which they tried to treat with multiple daily injection, but on (b)(6) 2022, the patient first went to the emergency room and was subsequently hospitalized. Further, she was transferred to the intensive care unit. Her highest blood glucose level was 600 mg/dl and had high ketone level which her healthcare professional assessed as dangerous/life threatening. Moreover, the infusion had been used for less than one day. During hospitalization, the patient received fluids of saline, insulin, and unspecified medication (drug name unknown) as corrective treatment which resolved the issue. On (b)(6) 2022, the patient was released from the hospital with chronic numbness through hand, feet, and face. Further, on (b)(6) 2022, the patient faced similar issue as the infusion set fell off during use due to which the patient experienced high blood glucose level which they tried to treat with correction multiple daily injections. This issue occurred with eight infusion sets. Moreover, they replaced the infusion set and insulin was resumed successfully. No further information available.
 
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Brand NameTRUSTEEL
Type of DeviceUNO CONTACT DETACH G29 60/6TCAP 10PK INT
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key14012559
MDR Text Key288586219
Report Number3003442380-2022-00493
Device Sequence Number1
Product Code FPA
UDI-Device Identifier05705244018426
UDI-Public05705244018426
Combination Product (y/n)Y
PMA/PMN Number
K041545
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation
Type of Report Initial
Report Date 04/05/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/05/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model Number1002833
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Date Manufacturer Received03/24/2022
Was Device Evaluated by Manufacturer? No Answer Provided

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