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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 Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)
Event Date 11/12/2023
Event Type  Injury  
Manufacturer Narrative
The product has been requested back for an investigation.At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The device history records (dhrs) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor and 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 "check if the sensor is inserted correctly" error message was reported with the adc device and customer was unable to obtain readings.As a result, customer experienced loss of consciousness and was unable to self-treat.The patient was given sugar by third-party as treatment for the diagnosis of hypoglycemia.There was no report of death or permanent impairment associated with this event.
 
Event Description
A "check if the sensor is inserted correctly" error message was reported with the adc device and customer was unable to obtain readings.As a result, customer experienced loss of consciousness and was unable to self-treat.The patient was given sugar by third-party as treatment for the diagnosis of hypoglycemia.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 performed on the returned sensor patch and no issue was observed.Data was extracted using approved software and extraction was successful.Sensor found to be in state 1 (storage state) and insertion failures were observed in the event log.The watermark was observed at the base of the tail indicating the sensor being properly inserted.The returned sensor was further investigated and de-cased.Performed an internal visual inspection on the sensor¿s pcba (printed circuit board assembly); no issues were observed.The returned battery voltage was measured to be within specification range.Performed an smu (source measurement unit) test while in the simvivo test fixture with key to ensure the sensor's electronics were functioning correctly, and the returned unit did not have any glucose reading issues.Poise voltage and sensor thermistor testing were both within specification, indicating the sensor was providing accurate glucose readings.Therefore, this issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
 
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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 Key18181438
MDR Text Key328630699
Report Number2954323-2023-50835
Device Sequence Number1
Product Code QLJ
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K213996
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 03/11/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model Number72081-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received03/04/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/17/2023
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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