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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE LTD FREESTYLE LIBRE 3; CONTINUOUS GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE LTD FREESTYLE LIBRE 3; CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 72081-01
Device Problem Low Readings (2460)
Patient Problems Dehydration (1807); Headache (1880); Hyperglycemia (1905); Dizziness (2194)
Event Date 05/31/2023
Event Type  Injury  
Manufacturer Narrative
Sensor (b)(6) has been returned and is currently undergoing investigation process.A follow up report will be submitted once all investigation activities are complete.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A low readings issue was reported with the abbott diabetes care (adc) device.A customer reported receiving an unspecified low scan on the sensor when compared to a competitor meter.The customer experienced symptoms described as "had to drink a lot", dizziness, and headache and was unable to self-treat, requiring insulin (type/dose unknown) injection from a non-healthcare professional for treatment.No further information was provided.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
Sensor (b)(6) has been returned and investigated.Visual inspection has been performed and no issues were observed on sensor patch.Data was extracted using approved software, and extraction was successful.Watermark was observed at the base of the sensor tail indicating that the sensor activated.The returned sensor was de-cased and visual inspection has been performed on pcba (printed circuit board assembly) and no issue were observed.The returned battery was measured and all results were within specification.Observed the sensor having an issues communicating with the evaluation module (evm) after de-casing.De-soldered the battery and soldered a known good battery to pcba.An extended investigation has been performed on the returned sensor.Performed a visual inspection on the returned sensor, no issues observed.Attempted to extract data from returned sensor after de-casing, but the sensor did not read.Performed a visual inspection on the returned sensors pcba (printed circuit board assembly), observed that the sensor¿s connector had been damage due to de-casing and is unable to be re-soldered/repaired due to the solder pads coming away from the pcba.Adc is unable to perform further testing at this time due to damage during de-casing.The dhr for the libre sensor and sensor kit indicated by the serial number provided by the customer was reviewed.The dhrs showed the libre sensor and sensor kits passed all tests prior to release and there was no indication that the product did not meet specifications.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A low readings issue was reported with the abbott diabetes care (adc) device.A customer reported receiving an unspecified low scan on the sensor when compared to a competitor meter.The customer experienced symptoms described as "had to drink a lot", dizziness, and headache and was unable to self-treat, requiring insulin (type/dose unknown) injection from a non-healthcare professional for treatment.No further information was provided.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
Sensor (b)(6) has been returned and investigated.Visual inspection has been performed and no issues were observed on sensor patch.Data was extracted using approved software, and extraction was successful.Sensor state 7 with event log 11, 224 & 227 and sensor state 8 with event log 9 are an indication that the sensor had terminated due to an intentional non-fatal error recognized by the sensor.This termination is an intended part of the sensors system and is not an indication of product non-conformance.Watermark was observed at the base of the sensor tail indicating that the sensor activated.The returned sensor was de-cased and visual inspection has been performed on pcba (printed circuit board assembly) and no issue were observed.The returned battery was measured and all results were within specification.Sensor got damaged during de-casing.An attempt was made to read sensor with evm (evaluation module) and failed to read patch data was received.De-soldered the battery and soldered a known good battery to pcba.An extended investigation has been performed on the returned sensor.Performed a visual inspection on the returned sensor, no issues observed.Attempted to extract data from returned sensor after de-casing, but the sensor did not read.Performed a visual inspection on the returned sensor's pcba (printed circuit board assembly), damage was observed on the molex connector due to de-casing.Unable to re-soldered/repaired due to the solder pads coming away from the pcba.Unable to perform smu (source measurement unit) testing without the molex connector connected.Therefore, this issue is unable to test.Section h6 (investigation findings) code c20 (no findings available) was selected, as adc was unable to perform further testing on the returned device.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A low readings issue was reported with the abbott diabetes care (adc) device.A customer reported receiving an unspecified low scan on the sensor when compared to a competitor meter.The customer experienced symptoms described as "had to drink a lot", dizziness, and headache and was unable to self-treat, requiring insulin (type/dose unknown) injection from a non-healthcare professional for treatment.No further information was provided.There was no report of death or permanent impairment associated with this event.
 
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Brand Name
FREESTYLE LIBRE 3
Type of Device
CONTINUOUS GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE LTD
range road
witney 12345 -700
UK  12345-7001
Manufacturer Contact
audra fuentes
1360 south loop road
alameda, CA 94502-7001
5107495297
MDR Report Key17244075
MDR Text Key318262444
Report Number2954323-2023-28376
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K223435
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 01/19/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date12/31/2023
Device Model Number72081-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2023
Initial Date Manufacturer Received 06/05/2023
Initial Date FDA Received06/30/2023
Supplement Dates Manufacturer Received10/13/2023
01/09/2024
Supplement Dates FDA Received11/09/2023
01/19/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/28/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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