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U.S. Department of Health and Human Services

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

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ABBOTT DIABETES CARE INC. FREESTYLE LIBRE MONITOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Lot Number 02Z178D
Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/30/2020
Event Type  No Answer Provided  
Event Description
Freestyle libre monitor has been giving consistently low readings of 114, and 120. Reporter states that she started to feel something was wrong her monitor on (b)(6) 2020; she has been underdosing or not administering corrective blood sugar doses due to inaccurate readings. She also, reports that two of her sensors didn't last the 14 days they fell off early.
 
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Brand NameFREESTYLE LIBRE MONITOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE INC.
MDR Report Key10419974
MDR Text Key203524629
Report NumberMW5096113
Device Sequence Number2
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 08/17/2020
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received08/17/2020
Device Operator
Device Expiration Date09/30/2020
Device Lot Number02Z178D
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
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: 08/17/2020 Patient Sequence Number: 1
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