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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE, INC. ABBOTT FREESTYLE LIBRE SENSOR, GLUCOSE, INVASIVE

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ABBOTT DIABETES CARE, INC. ABBOTT FREESTYLE LIBRE SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Hyperglycemia (1905); Nausea (1970); Vomiting (2144); Diabetic Ketoacidosis (2364); Loss of consciousness (2418)
Event Date 07/01/2021
Event Type  Injury  
Event Description
The patient is from my (b)(6) (underserved) clinic who had a near life-threatening experience with her libre. She has typical up and down, out of control diabetes, a1c above 10% that i see in that clinic. She has painful neuropathy, gastroparesis, proteinuria, retinopathy. Sadly common complications for our patients; 3 weeks ago she started a new libre and she went from ~30% tir to 95% tir. Her blood sugars were unbelievable. Nothing else changed. But after the few days of wearing the sensor she was increasingly nauseated which she attributed to her gastroparesis. On july 1st she vomited repeatedly and became unconscious. The paramedics found her bg to be >600 and she was in severe dka which required a 4 day hospitalization. Her libre read 116 and steady at the same time. When she put on a new libre she was back to her usual pattern of highs and lows. The daily log that shows july 20 - 23 is her "usual" pattern, the one from june 30 - july 1 represents the abnormal. She knew to do a fingerstick if there was some discordance between her symptoms and her bg's but with her normal libre data she thought she was fine. Fda safety report id # (b)(4).
 
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Brand NameABBOTT FREESTYLE LIBRE
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE, INC.
MDR Report Key12239373
MDR Text Key264576797
Report NumberMW5102812
Device Sequence Number1
Product Code MDS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 07/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/27/2021 Patient Sequence Number: 1
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