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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 2; SENSOR, GLUCOSE, INVASIVE
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ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 2; SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number MCGA293-J0864
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)
Event Date 06/08/2021
Event Type  Injury  
Event Description
Hypo hyper glycemic event; this is the second sensor out of 4 used total with the freestyle libre2 that has had major variances from an actual finger stick glucometer.I'm talking 100 points.My libre alarm went off telling me i was having high glucose.It read 265 my actual glucometer said 365 which i checked several times.I did a rescue dose of insulin and after a few hours my libre went off saying low glucose alert of 55 and my actual meter stated 103.Constantly getting error messages despite getting a new sensor.Another time yesterday the libre was reading 145 and my actual my actual meter registered at 74 and dropping which lead me to have a pretty bad hypo event because i didn't correct the low as it started trending down.This product has beyond disappointed me and could have lead to a life threatening event.I can't even explain my frustration.Fda safety report id# (b)(4).
 
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Brand Name
FREESTYLE LIBRE 2
Type of Device
SENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE INC.
MDR Report Key11982838
MDR Text Key255947231
Report NumberMW5101825
Device Sequence Number2
Product Code MDS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/09/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received06/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberMCGA293-J0864
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Other; Required Intervention;
Patient Age36 YR
Patient Weight62
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