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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 Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364); Diaphoresis (2452); Decreased Appetite (4569)
Event Date 12/01/2022
Event Type  Injury  
Manufacturer Narrative
The product has been requested for investigation.A follow-up report will be filed once additional information is obtained.The date of incident is unknown.The dates entered in section b3 is based on the customer's report of "(b)(6) 2022".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.
 
Event Description
An error message was reported with the adc device.Customer received an error 7 message on their meter display and was unable to obtain readings.As a result, customer experienced loss of appetite, "trigger", sweating and chills.Customer was taken to the hospital were they were administered a rapid insulin intravenously by healthcare professional.There was no report of death or permanent impairment associated with this event.
 
Event Description
An error message was reported with the adc device.Customer received an error 7 message on their meter display and was unable to obtain readings.As a result, customer experienced loss of appetite, "trigger", sweating and chills.Customer was taken to the hospital were they were administered a rapid insulin intravenously by healthcare professional.There was no report of death or permanent impairment 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.Dhrs (device history review) for the libre reader was reviewed and the dhrs showed the libre reader passed all tests prior to release.Clinical data was reviewed and confirmed that the 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 led 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.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 Key17184159
MDR Text Key317680862
Report Number2954323-2023-26613
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeFR
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 09/26/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2023
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? No
Date Manufacturer Received09/05/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/22/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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