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U.S. Department of Health and Human Services

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

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ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 2 CGM SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Lot Number MULTIPLE
Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Defective Device (2588)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
Abbott freestyle libre continuous glucose monitor: over the past 4 + months, 8 of 9 sensors have been defective. Three failed to start, two quit well before the advertised 14 days; three gave very low, inaccurate readings (50 or more less than finger stick). Quality control has been abysmal. Fda safety report id # (b)(4).
 
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Brand NameFREESTYLE LIBRE 2 CGM SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE INC.
MDR Report Key13395033
MDR Text Key284867139
Report NumberMW5107081
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 Patient
Type of Report Initial
Report Date 01/27/2022
8 Devices were Involved in the Event: 1   2   3   4   5   6   7   8  
1 Patient was Involved in the Event
Date FDA Received01/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberMULTIPLE
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 01/28/2022 Patient Sequence Number: 1
Treatment
METFORMIN
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