MAUDE Adverse Event Report: MEDTRONICS INFUSION SET

Lot Number 5173493

Device Problems Nonstandard Device (1420); Low Test Results (2458)

Patient Problems Hypoglycemia (1912); Seizures (2063); Pregnancy (3193)

Event Date 09/14/2017

Event Type  Injury  

Event Description

I received a letter from medtronics stating they are recalling certain infusion sets. I had to go on a website to check my lot numbers to see if mine were on the recall list. I checked today and the box i have been using for the past 6-8 weeks was on the recall list. I have had to use my glucagon emergency kit twice since opening this box of infusion sets. Yesterday, on (b)(6) 2017, i checked my blood sugar before bed and it was 120. I ate a package of fruit snacks just to be safe as i had been experiencing random blood sugar drops. At about midnight i had a seizure due to my blood sugar dropping so fast. My blood sugar was then 30. The last occurrences have been checking my blood sugar before my work day ends at 4 pm and have table blood sugar. I pick up my kids and drive home and start to prepare dinner. This whole process takes about an hour. At least twice i needed help as my blood sugar suddenly dropped to the 20s and 30s. I am currently (b)(6) pregnant so i initially thought it was the pregnancy causing these extreme blood sugar drops.

• Brand Name: INFUSION SET
• Type of Device: INFUSION SET
• Manufacturer (Section D): MEDTRONICS
• MDR Report Key: 6876061
• MDR Text Key: 86745964
• Report Number: MW5072209
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2017
• Is this an Adverse Event Report?: Yes

Device Operator

• Device Expiration Date: 01/01/2020
• Device Lot Number: 5173493
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 09/18/2017 Patient Sequence Number: 1