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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 Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
Patient Problems Hypoglycemia (1912); Discomfort (2330); Shaking/Tremors (2515); Convulsion/Seizure (4406)
Event Date 09/17/2023
Event Type  Injury  
Event Description
A "replace sensor" error message was reported with the adc device and the customer was unable to obtain readings.As a result, the customer experienced "tissue discomfort", tremors, and a seizure.The customer was unable to self-treat, requiring third-party administration of fruit for treatment.There was no report of death or permanent impairment 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 review) for the libre sensor and libre sensor kit were reviewed and the dhrs showed the libre sensor and libre sensor kits 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 "replace sensor" error message was reported with the adc device and the customer was unable to obtain readings.As a result, the customer experienced "tissue discomfort", tremors, and a seizure.The customer was unable to self-treat, requiring third-party administration of fruit for treatment.There was no report of death or permanent impairment 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 and cracked sensor neck was observed.The cause of the cracked sensor neck is likely attributed to shipment of the used sensor back to adc for investigation.Sensor state 5 is an indication of normal sensor termination and full wear by the user, therefore the cracked sensor neck observed during investigation occurred post-wear.In addition, the passing of all tests during the investigation indicates that the cracked sensor neck did not impact the sensor's ability to still generate an accurate glucose reading.Current was applied to the sensor to perform sim vivo testing (simulation of the electrical signal produced by the sensor tail) and poise voltage testing.All results were within specification.Therefore 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 Key17834026
MDR Text Key324473184
Report Number2954323-2023-42954
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeSP
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 10/16/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number71992-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received10/15/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/04/2023
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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