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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE SENSOR 14DAYS SENSOR GLUCOSE INVASIVE

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ABBOTT DIABETES CARE INC. FREESTYLE LIBRE SENSOR 14DAYS SENSOR GLUCOSE INVASIVE Back to Search Results
Device Problems Loss of or Failure to Bond (1068); Incorrect, Inadequate or Imprecise Resultor Readings (1535); Material Separation (1562); Detachment of Device or Device Component (2907)
Patient Problems Myocardial Infarction (1969); Test Result (2695); No Code Available (3191)
Event Date 11/27/2018
Event Type  Injury  
Event Description
Reporter is making this complaint on behalf of his wife. He alleges the sensor was placed on his wife's arm and the material separated causing the sensor to fall off. Reporter·believes the device is defective and very concerned about the numbers the sensor reads. His wife relies on the sensor for her insulin intake and he believes sensor was reading inaccurate numbers and hence the wrong treatment of insulin administered to his wife. He alleges his wife suffered two heart attacks and the doctors were not able to tell him how the heart attacks happened but he believes it stems from the faulty sensors that was producing inaccurate results. He reported to manufacturer who replaced the defective device. Reporter is still concerned and advises he has notified (b)(6) not to pay for the device, and he has stopped using the device for his wife. He wants the fda to look into the safety of this device as he is really concerned about the device. His wife has previously used the todays sensor and they worked fine but the manufacturer doesn't make those anymore. Reporter advised the defective sensor looks like it had "exploded" causing the materials to separate and fall off. He thinks the device if not investigated and recalled can cause harm to patients who use these devices.
 
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Brand NameFREESTYLE LIBRE SENSOR 14DAYS
Type of DeviceSENSOR GLUCOSE INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE INC.
MDR Report Key9238902
MDR Text Key164080537
Report NumberMW5090649
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 Family Member or Friend
Type of Report Initial
Report Date 10/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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: 10/24/2019 Patient Sequence Number: 1
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