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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 71953-01
Device Problem No Device Output (1435)
Patient Problems Hyperglycemia (1905); Loss of consciousness (2418)
Event Date 08/17/2021
Event Type  Injury  
Manufacturer Narrative
At this time product has not yet been returned and a valid serial was not provided for the strips.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs (device history record) for the libre reader were reviewed and the dhrs showed the libre reader passed all tests prior to release.Clinical and stability were reviewed and confirmed that precision strips continue to be safe, effective, and perform as intended in the field.Stability data for precision strips was reviewed and showed no anomalies or non-conformances that could have lead to the complaint.A tripped trend review was conducted for the reported complaint and precision strips, no trends were identified that would indicate any product related issues.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The exact date the incident occurred 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 port issue was reported with the use of the adc freestyle libre 2 reader.A caller reported that he was unable to obtained scans due to the test strip opening not work correctly and as a result, the customer experienced a loss of consciousness and was unable to self-treat.The customer was seen at a hospital where he was treated with insulin (dose/type unknown) for the diagnosis of hyperglycemia.No further information was reported.There was no report of death or permanent impairment associated with this event.
 
Event Description
A port issue was reported with the use of the adc freestyle libre 2 reader.A caller reported that he was unable to obtained scans due to the test strip opening not work correctly and as a result, the customer experienced a loss of consciousness and was unable to self-treat.The customer was seen at a hospital where he was treated with insulin (dose/type unknown) for the diagnosis of hyperglycemia.No further information was reported.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
Reader (b)(6) has been returned and investigated.Visual inspection has been performed, no issues were observed.Reader turns on with button.Strip insertion was attempted and port issue were observed.The reader was de-cased and visual inspection was performed.Contamination was observed.Issue is not confirmed to use.All pertinent information available to abbott diabetics 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 Key12388054
MDR Text Key268887844
Report Number2954323-2021-82298
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 08/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number71953-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received07/24/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/14/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexMale
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