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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE, INC. FREESTYLE LIBRE SENSOR KIT AND READER 14 DAY SENSOR, GLUCOSE, INVASIVE

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ABBOTT DIABETES CARE, INC. FREESTYLE LIBRE SENSOR KIT AND READER 14 DAY SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Calibration Problem (2890)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/11/2020
Event Type  Injury  
Event Description
As user of freestyle libre 14 day cgm for 1+ years, recently since (b)(6) 2019 noticing 20-35 mg/dl error in comparison to ref lab and test strips. This has been noticed with latest replacement sensors sent by company by fedex and despite trouble shooting with their technical support staff - all guidelines were met. In past error 1 year ago had been less +/- 10 mg/dl. Yesterday (b)(6) 2020 in fasting sugar as measured in a sutter health, palo alto lab serum was 121 mg/dl while freestyle libre gave 94 reading as measured several times within 1 - 5 mins of blood draw. One touch ultra test strips in contrast was 123 well in tight range. This is unacceptable about 23% off. I have experienced similarly off readings repeatedly been on call on nearly every 14 days sensor 2 in december, 2 in january and ow, this is the latest replacement one sent by them applied (b)(6) 2020. It seems company is shipping sensors that are not calibrated or out of whack. The above is the ref test range. Freestyle libre 14 day gave 94 reading within 1 and 5 mins of blood draw. Multiple lots (b)(6) 2019 - (b)(6) 2020. Fda safety report id# (b)(4).
 
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Brand NameFREESTYLE LIBRE SENSOR KIT AND READER 14 DAY
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE, INC.
MDR Report Key9720617
MDR Text Key180099544
Report NumberMW5093019
Device Sequence Number5
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 02/12/2020
5 Devices were Involved in the Event: 1   2   3   4   5  
1 Patient was Involved in the Event
Date FDA Received02/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
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?
Type of Device Usage

Patient Treatment Data
Date Received: 02/14/2020 Patient Sequence Number: 1
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