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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 71992-01
Device Problem Low Readings (2460)
Patient Problems Hypoglycemia (1912); Muscle Weakness (1967); Nausea (1970); Loss of consciousness (2418)
Event Date 10/30/2022
Event Type  Injury  
Event Description
A caller reported a low reading with the adc device.The caller reported an unspecified low sensor reading and experienced weakness, nausea, and lost consciousness.The customer was able to eat meal to raise glucose after regaining consciousness.As the caller did not provide readings from time of event, although low sensor readings were reported, it cannot be confirmed if sensor indicated hypoglycemia at time of event.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint, and it has been determined that there was no indication that the product did not meet specification.The dhrs (device history record) for the libre sensor and libre sensor kit were reviewed, and the dhrs showed the libre sensor and libre sensor kit passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A caller reported a low reading with the adc device.The caller reported an unspecified low sensor reading and experienced weakness, nausea, and lost consciousness.The customer was able to eat meal to raise glucose after regaining consciousness.As the caller did not provide readings from time of event, although low sensor readings were reported, it cannot be confirmed if sensor indicated hypoglycemia at time of event.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
Sensor (b)(6).Has been returned and investigated.The sensor plug is fully seated and no issues were observed.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).Inspected the plug assembly.Visual inspection was performed on the pcba(printed circuit board assembly) triangle and blood contamination along with debris that appear to be flakes of material (skin) was observed.Current was applied to the sensor to perform accuracy testing while in the test fixture.All results were within specification.Poise voltage and sensor thermistor testing were both within specification, indicating the sensor was providing accurate glucose readings.The debris observed is most likely the result of the sensor plug being removed during product return investigation.The passing of all tests is an indication that the blood contamination and debris present did not impact the sensor¿s ability to generate an accurate glucose reading.Therefore, the issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
 
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Brand Name
FREESTYLE LIBRE 2
Type of Device
FLASH GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE INC
1360 south loop road
alameda CA 94502 7001
Manufacturer Contact
audra fuentes
1360 south loop road
alameda, CA 94502-7001
5107495297
MDR Report Key15795220
MDR Text Key303625163
Report Number2954323-2022-41705
Device Sequence Number1
Product Code QLG
UDI-Device Identifier00357599800000
UDI-Public00357599800000
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K193371
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
Report Date 03/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date12/31/2022
Device Model Number71992-01
Device Catalogue Number71992
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received02/18/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/24/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age85 YR
Patient SexFemale
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