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U.S. Department of Health and Human Services

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

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ABBOTT DIABETES CARE, INC. FREESTYLE LIBRE SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Device Displays Incorrect Message (2591)
Patient Problems Hypoglycemia (1912); Syncope/Fainting (4411)
Event Date 05/18/2022
Event Type  Injury  
Event Description
I use the abbott freestyle libre to monitor my blood glucose. On the 18th, i received a error message that my sensor ended and i needed to reapply a sensor, however i had applied and activated a new sensor before going to bed. I contacted abbott about my problem and they sent me a new sensor. I reapplied the new sensor and received another error message on may 24th. I contacted abbott again and they sent me another sensor. I also contacted my endocrinologist to let her know about my problem with my freestyle libre and to request testing strips for my onetouch verio flex strips. This time, i used my old freestyle libre to see if maybe my meter was the problem. 1 week after activating my new sensor with my old meter, i received the message that my sensor had ended. I'm hesitant to refill my freestyle libre sensor prescription due to all of the recent sensor malfunctions. I have had multiple episodes of hypoglycemia, one of which occurred at work and led to a syncopal episode. Fda safety report id# (b)(4).
 
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Brand NameFREESTYLE LIBRE
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE, INC.
MDR Report Key14695702
MDR Text Key294245499
Report NumberMW5110326
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/10/2022
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received06/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 06/14/2022 Patient Sequence Number: 1
Treatment
FREESTYLE LIBRE METER (OLD); ONETOUCH VERIO FLEX STRIPS
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