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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 Premature Discharge of Battery (1057)
Patient Problems Hyperglycemia (1905); Loss of consciousness (2418)
Event Date 10/19/2023
Event Type  Injury  
Event Description
A battery/power issue was reported with the adc device.The customer was unable to obtain readings due to a fast-draining battery.The daughter reported that their mother had the feeling of losing consciousness and was treated with insulin.It was additionally reported that the customer had heart fibrillation and was taken by an ambulance and was admitted three times.Adc customer service is currently making additional attempts to gain further information, and a follow-up will be submitted when more information is obtained.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 date of event is unknown.The date entered in section b3 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 battery/power issue was reported with the adc device.The customer was unable to obtain readings due to a fast-draining battery.The daughter reported that their mother had the feeling of losing consciousness and was treated with insulin.It was additionally reported that the customer had heart fibrillation and was taken by an ambulance and was admitted three times.Adc customer service is currently making additional attempts to gain further information, and a follow-up will be submitted when more information is obtained.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.The dhrs (device history review) for the libre reader were reviewed and the dhrs showed the libre reader passed all tests prior to release.In addition, the review determined that the correct cable and adapter were part of the reader kit pack and there was no indication that the product did not meet specifications.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 Key18039674
MDR Text Key326974436
Report Number2954323-2023-47871
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeNO
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 11/14/2023
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 Number71953-01
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/19/2023
Initial Date FDA Received10/31/2023
Supplement Dates Manufacturer Received11/06/2023
Supplement Dates FDA Received11/14/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/23/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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