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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); Chills (2191); Loss of consciousness (2418); Diaphoresis (2452)
Event Date 07/28/2021
Event Type  Injury  
Manufacturer Narrative
Physical investigation of product is not anticipated as reporter indicated device was discarded.Extended investigation will be performed per adc's established processes and procedures and a follow-up report will be submitted upon completion of investigation.In the event that unanticipated product is received, a physical investigation will be performed.The device mfg 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
Customer reported that the adc freestyle libre 2 sensor failed on the day of application and was therefore unable to test.Customer experienced sweat, chills and a loss of consciousness and required treatment with glucagon by his wife.Customer had contact with healthcare provider and blood test was performed, however no further treatment was reported.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.A tripped trend review was completed for the reported complaint and fs libre 2 sensors, and a trend was investigated where a probable root cause was related to an insertion issue.However without a valid sensor number or product return, the root cause of the particular issue associated with this complaint is unknown and cannot be further determined.Clinical data was reviewed and confirmed that freestyle libre 2 sensors continue to be safe, effective, and perform as intended in the field.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
Customer reported that the adc freestyle libre 2 sensor failed on the day of application and was therefore unable to test.Customer experienced sweat, chills and a loss of consciousness and required treatment with glucagon by his wife.Customer had contact with healthcare provider and blood test was performed, however no further treatment was reported.There was no report of death or permanent injury 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 Key12576813
MDR Text Key274746963
Report Number2954323-2021-87092
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeGM
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 06/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
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? No
Initial Date Manufacturer Received 09/24/2021
Initial Date FDA Received10/05/2021
Supplement Dates Manufacturer Received06/06/2022
Supplement Dates FDA Received06/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/24/2021
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 SexMale
Patient Weight95 KG
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