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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); Shaking/Tremors (2515)
Event Date 11/28/2022
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 manufacturing 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
A customer reported via webform a sensor error message with the adc device and was unable to obtain readings.As a result, customer experienced "shaking because glucose went low" and was unable to self-treat.Customer required third-party intervention by roommate who provided sugar as 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.The sensor plug is properly seated and no physical damage was observed on the sensor patch.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 3 (indicating the sensor was paired within the last 14 days).Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.Sim vivo testing (simulation of the electrical signal produced by the sensor tail) was performed and all results were within specification.No malfunction or product deficiency was identified.Therefore issue is not confirmed.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 kits were reviewed and the dhrs showed the libre sensor and libre sensor kits passed all tests prior to release.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A customer reported via webform a sensor error message with the adc device and was unable to obtain readings.As a result, customer experienced "shaking because glucose went low" and was unable to self-treat.Customer required third-party intervention by roommate who provided sugar as 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 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 Key16076309
MDR Text Key306405913
Report Number2954323-2022-47586
Device Sequence Number1
Product Code QLG
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 01/23/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date05/31/2023
Device Model Number71992-01
Device Catalogue Number71992
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2022
Date Manufacturer Received01/10/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/30/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexFemale
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