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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 14 DAY; FLASH GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC FREESTYLE LIBRE 14 DAY; FLASH GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 71940-01
Device Problem Device Displays Incorrect Message (2591)
Patient Problems Fainting (1847); Nausea (1970); Confusion/ Disorientation (2553)
Event Date 06/17/2019
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.The device mfg date is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
Customer reported receiving a "scan again in 10" message for more than two hours while wearing an adc freestyle libre sensor.Customer reported he/she was undergoing a dental procedure and, unable to obtain a glucose result, experienced nausea, confusion, strange motor coordination, and fainting.Customer was seen at a hospital and treated with unspecified "serum", rehidrat oral electrolyte mixture, floratil 200mg oral probiotic, and zofran 400mg anti-nausea and vomiting medication.There was no report of death or permanent impairment associated with this event.
 
Event Description
Customer reported receiving a "scan again in 10" message for more than two hours while wearing an adc freestyle libre sensor.Customer reported he/she was undergoing a dental procedure and, unable to obtain a glucose result, experienced nausea, confusion, strange motor coordination, and fainting.Customer was seen at a hospital and treated with unspecified "serum", rehidrat oral electrolyte mixture, floratil 200mg oral probiotic, and zofran 400mg anti-nausea and vomiting medication.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
No product has been returned.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.  (dhrs) (device history review) for the libre sensor and libre sensor kit was reviewed and the dhrs showed the libre sensor and libre sensor kit passed all tests prior to release.    all review activities conducted above, including but not limited to the final release testing specifically associated with the manufacture of this product, are sufficient information in order to show if the product has met specifications prior to release.  if the product is returned, the case will be re-opened and a physical investigation will be performed.
 
Manufacturer Narrative
Section h4 (device mfg date) has been updated based on the returned product download.Sensor (b)(4) has been returned and investigated.Visual inspection was performed on the returned sensor patch, no issues were observed.Extracted data using approved software, sensor was found to be in sensor state 5 (indicating normal termination).Sensor plug was returned.Removed sensor plug and inspected plug assembly, no issues were observed.Sensor was reprogrammed and current was applied to perform linearity testing while in the test fixture.All results were within specification.No malfunction or product deficiency was identified.
 
Event Description
Customer reported receiving a "scan again in 10" message for more than two hours while wearing an adc freestyle libre sensor.Customer reported he/she was undergoing a dental procedure and, unable to obtain a glucose result, experienced nausea, confusion, strange motor coordination, and fainting.Customer was seen at a hospital and treated with unspecified "serum", rehidrat oral electrolyte mixture, floratil 200mg oral probiotic, and zofran 400mg anti-nausea and vomiting medication.There was no report of death or permanent impairment associated with this event.
 
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Brand Name
FREESTYLE LIBRE 14 DAY
Type of Device
FLASH GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE INC
1360 south loop road
alameda CA 94502 7001
MDR Report Key8937920
MDR Text Key155777792
Report Number2954323-2019-06614
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 03/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number71940-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2020
Date Manufacturer Received02/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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