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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 2 SENSORS SENSOR, GLUCOSE, INVASIVE

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ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 2 SENSORS SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem Insufficient Information (4580)
Event Date 08/04/2022
Event Type  malfunction  
Event Description
The freestyle libre 2 sensors are highly inaccurate, which could lead to in improper use of insulin, resulting in hospitalizations. One of our patients kept getting low readings on the libre. One of the times it read 59, when her finger stick read 122. There were other times when the libre read high (250) and her sugar was actually 134 upon finger stick. This error occurs on all different days throughout the 14 day sensor period. This should not be off this much and be allowed on the market. I have heard this complaint from multiple patients. Fda safety report id # (b)(4).
 
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Brand NameFREESTYLE LIBRE 2 SENSORS
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE INC.
MDR Report Key15192968
MDR Text Key297686258
Report NumberMW5111365
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 08/05/2022
3 Devices were Involved in the Event: 1   2   3  
0 Patients were Involved in the Event:
Date FDA Received08/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes

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