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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 Bruise/Contusion (1754); Hypersensitivity/Allergic reaction (1907); Hypoglycemia (1912); Loss of consciousness (2418); Confusion/ Disorientation (2553); Convulsion/Seizure (4406)
Event Date 05/18/2023
Event Type  Injury  
Event Description
A "replace sensor" error message was reported with the adc device and customer was unable to obtain readings.As a result, customer experienced a loss of consciousness, seizure, confusion, and bruising, and site sensitivity, requiring third-party administration of glucagon for treatment.There was no report of death or permanent impairment associated with this event.
 
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 in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
 
Manufacturer Narrative
Sensor (b)(6) has been returned and investigated.The sensor plug is properly seated and no physical damage was observed.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).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, the issue is not confirmed.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 customer was unable to obtain readings.As a result, customer experienced a loss of consciousness, seizure, confusion, and bruising, and site sensitivity, requiring third-party administration of glucagon for treatment.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
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.Sensor (b)(6) has been returned and investigated.The sensor plug is properly seated and no physical damage was observed.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).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, the issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.This serves as a correction report.Section h10 (addtl mfg narrative) was incorrectly documented in the previous report.The correction has been made here.
 
Event Description
A "replace sensor" error message was reported with the adc device and customer was unable to obtain readings.As a result, customer experienced a loss of consciousness, seizure, confusion, and bruising, and site sensitivity, requiring third-party administration of glucagon for treatment.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 Key17140783
MDR Text Key317291345
Report Number2954323-2023-25487
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,Followup
Report Date 01/03/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2023
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 Received12/06/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/09/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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