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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE; FLASH GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC. FREESTYLE LIBRE; FLASH GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 71702-01
Device Problem Device Displays Incorrect Message (2591)
Patient Problems Hypoglycemia (1912); Nausea (1970); Vomiting (2144); Dizziness (2194); Sweating (2444)
Event Date 11/25/2017
Event Type  Injury  
Manufacturer Narrative
The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.Device mfg date is the date abbott became ware of the event as the manufacture date is unknown.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
Customer reported receiving a "scan again in 10" message for 3 hours while wearing the adc freestyle libre sensor.Customer further reported he experienced dizziness, nausea, vomiting, and sweating and at the time did not have any test strips to perform a finger stick glucose test.The customer was seen at a hospital where he was diagnosed with hypoglycemia and treated with intravenous glucose serum (5%).There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
Visual inspection was performed on the returned sensor and no issues were observed.Data was extracted using approved software.Sensor was found to be in state 5 (normal termination) and all glucose counts were within specifications.Removed sensor plug and inspected the connector.All three contacts were installed properly.It has been determined there was no product malfunction.(suspect medical device name), (single use device) and (labeled for single use) were incorrectly documented in the initial mdr 30 day report.Sections have been updated.
 
Event Description
Customer reported receiving a "scan again in 10" message for 3 hours while wearing the adc freestyle libre sensor.Customer further reported he experienced dizziness, nausea, vomiting, and sweating and at the time did not have any test strips to perform a finger stick glucose test.The customer was seen at a hospital where he was diagnosed with hypoglycemia and treated with intravenous glucose serum (5%).There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
(serial number) was incorrectly documented in the initial and follow up #1.Has been updated to the corrected (b)(4).
 
Event Description
Customer reported receiving a "scan again in 10" message for 3 hours while wearing the adc freestyle libre sensor.Customer further reported he experienced dizziness, nausea, vomiting, and sweating and at the time did not have any test strips to perform a finger stick glucose test.The customer was seen at a hospital where he was diagnosed with hypoglycemia and treated with intravenous glucose serum (5%).There was no report of death or permanent impairment associated with this event.
 
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Brand Name
FREESTYLE LIBRE
Type of Device
FLASH GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE INC.
1360 south loop road
alameda CA 94502 7001
Manufacturer Contact
devin dirstine
1360 south loop road
alameda, CA 94502-7001
5108644391
MDR Report Key7136651
MDR Text Key95446304
Report Number2954323-2017-08981
Device Sequence Number1
Product Code PZE
Combination Product (y/n)N
PMA/PMN Number
P160030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup
Report Date 01/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number71702-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2017
Date Manufacturer Received01/28/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/27/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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