MAUDE Adverse Event Report: UNKNOWN DIABETIC INFUSION PUMP; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Obstruction of Flow (2423)

Patient Problems Hyperglycemia (1905); Vomiting (2144)

Event Date 05/07/2013

Event Type  Injury  

Event Description

In accordance with 21 cfr 803.22 (b)(2), we are notifying you that on (b)(6) 2013 patient reported experiencing persistent occlusions with elevated blood glucose levels.Patient stated she experienced elevated blood glucose levels caused by occlusions.Patient is using a competitor's infusion set.Patient reported that on (b)(6) 2013 she began vomiting every 10 minutes, tested her blood glucose level with a reading of hi on her meter; a competitor's meter.Patient stated she gave herself an injection of 5 units of insulin without outside assistance.Patient reported an hour later, she tested again with a reading of hi, so she gave herself another 5 units of insulin via injection.Patient stated she went to sleep and her mother continued to give her hourly injections of 5 units of insulin.Patient reported she would not have been able to give herself the insulin injections that were administered by her mother.No medical attention was sought for treatment of the elevated blood glucose levels.Patient stated 2 hours after her last hi reading her blood glucose level was 450 mg/dl.Patient's target blood glucose range is 100-200 mg/dl.Patient attributed her elevated readings to the occlusions.Patient switched to her old infusion device and has been using it since then.Attempts to follow up with the patient were unsuccessful.Manufacturer of the infusion device is unknown as the patient did not have the accessories with her.Alleged infusion set in use was not made by this manufacturer.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DIABETIC INFUSION PUMP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17523907
• MDR Text Key: 321109964
• Report Number: MW5130855
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/04/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1