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U.S. Department of Health and Human Services

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

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ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 2 SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problems Break (1069); Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/22/2021
Event Type  malfunction  
Event Description
Causes wrong doses of insulin; sensor and monitor worked for 24 hours and stopped working. Monitor malfunctioned and wouldn't read after 24 hours. Plus alarm went off constantly prior to the 24 hours. I filed a separate complaint regarding my device that is the same. Both sensor and device was working. We got 3 readings before it stopped. Device said to replace sensor. Sensor is supposed to work for 14 days before replacing. When i searched the intranet, i saw many bad reviews on this product. Not sure why this agency hasn't stepped in already. Elderly are having to pay out of pocket in some cases and they are on fixed incomes. Something needs to be done. I hope you log a full investigation. Also read the comments from consumers. Abbott needs to be stopped until all issues are rectified. They can't possibly expect consumers, who are relying on these devices and sensors to check blood sugar levels several times a day, call abbott for replacements sensors and/or devices. That's ridiculous! and you are the only agency that can stop this from happening. Fda safety report id# (b)(4).
 
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Brand NameFREESTYLE LIBRE 2
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE INC.
MDR Report Key12066815
MDR Text Key259365699
Report NumberMW5102145
Device Sequence Number2
Product Code MDS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/23/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received06/24/2021
Is this an Adverse Event Report? No
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: 06/24/2021 Patient Sequence Number: 1
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