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INFUSION DEVICES - UNKOWN Back to Search Results
Lot Number UNKNOWN
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. The patient faced issues with infusion set's tubing as it did not deliver insulin. The patient felt sick as her blood glucose was raised and she treated it with multiple daily injections. She went to the emergency room and stayed there for few hours and was subsequently hospitalized in the step-down intensive care unit. Upon arrival in emergency, her blood glucose was 595 mg/dl and she experienced diabetic ketoacidosis. The patient was admitted to hospital and the health care professional assessed the ketone level as dangerous/life threatening. The patient received insulin drip, intravenous bag fluids with potassium as corrective treatment which resolved the issue. The patient was hospitalized for 2 days. Reportedly, she was unsure about any incomplete bolus alerts. No further information available.
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Manufacturer Contact
aaholmvej 1-3
lejre, 4320
MDR Report Key8450939
MDR Text Key139798462
Report Number3003442380-2019-00695
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2019
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