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U.S. Department of Health and Human Services


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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.
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Type of DeviceINFUSION SET
Manufacturer (Section D)
MDR Report Key6876061
MDR Text Key86745964
Report NumberMW5072209
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received09/18/2017
Is this an Adverse Event Report? Yes
Device Operator
Device Expiration Date01/01/2020
Device Lot Number5173493
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