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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT

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AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT Back to Search Results
Model Number 1002817
Device Problem Appropriate Term/Code Not Available (3191)
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 as the infusion set was not fully inserted in the body. Therefore, the patient tried to treat it with a bolus via the pump, but on (b)(6) 2021, she went to the emergency room due to diabetic ketoacidosis. Her highest blood glucose level was 500 mg/dl and the infusion had been used for one day. The patient had high ketone levels which the healthcare professional assessed not to be dangerous/life threatening. During her stay in the emergency room, she received fluids of saline, insulin and unspecified medication (drug name unknown) intravenously, which resolved the issue. On (b)(6) 2021, the patient was released from the emergency room with no permanent damage to the patient. Previously, on (b)(6) 2021 and (b)(6) 2021 went to the emergency room due to same issue. Her highest blood glucose level was 1100 mg/dl for both emergency visits. On (b)(6) 2021 and (b)(6) 2021, the patient was released from the emergency room, respectively. No further information available.
 
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Brand NameAUTOSOFT 90
Type of DeviceUNO INSET II 60/6 GREY TCAP 10PK INT
MDR Report Key12597043
MDR Text Key275366839
Report Number3003442380-2021-00536
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
PMA/PMN Number
K032854
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
Report Date 10/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1002817
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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