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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 Problem Device Alarm System (1012)
Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364); Loss of consciousness (2418); Diaphoresis (2452)
Event Date 08/25/2023
Event Type  Injury  
Event Description
An alarm issue was reported with the adc device.Customer experienced a signal loss and was unable to obtain readings and receive glucose alarms.As a result, customer was not alerted of changes in glucose level and experienced hyperglycemia with symptoms described as sweating, slow breathing, and a loss of consciousness and was unable to self-treat, requiring treatment of insulin and "solutions" by a hcp for a diabetic ketoacidosis diagnosis.No further treatment was indicated.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
Additional information: section d4 (udi) was updated.Additional investigation has been conducted for the reported complaint.The user reported signal loss and was unable to obtain readings and receive glucose alarms in freestyle librelink app.Attempts to replicate the users complaint using a similar configuration was performed.The reported issue was unable to be replicated and the system functioned as intended.There were no issues identified with the freestyle librelink app during replication that would have led to the reported issue.No malfunction or product deficiency was identified.If the product is returned, the case will be re-opened, and a physical investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
An alarm issue was reported with the adc device.Customer experienced a signal loss and was unable to obtain readings and receive glucose alarms.As a result, customer was not alerted of changes in glucose level and experienced hyperglycemia with symptoms described as sweating, slow breathing, and a loss of consciousness and was unable to self-treat, requiring treatment of insulin and "solutions" by a hcp for a diabetic ketoacidosis diagnosis.No further treatment was indicated.There was no report of death or permanent impairment associated with this event.
 
Event Description
An alarm issue was reported with the adc device.Customer experienced a signal loss and was unable to obtain readings and receive glucose alarms.As a result, customer was not alerted of changes in glucose level and experienced hyperglycemia with symptoms described as sweating, slow breathing, and a loss of consciousness and was unable to self-treat, requiring treatment of insulin and "solutions" by a hcp for a diabetic ketoacidosis diagnosis.No further treatment was indicated.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 the most probable root causes associated with this failure mode are software/data corruption, or misuse.However, mitigations are in place to reduce and prevent such issues.All vital functions are monitored by the system and, when necessary, function is suspended to safeguard against inaccurate results.Labeling is provided to instruct the user on the intended use of all vital parts of the system to minimize misuse.All complaints and complaint trends are investigated to determine if there is a product defect/ deficiency.If a product defect/ deficiency is identified, a risk evaluation is completed and compared to the risk management report, to ensure the risk profile has not changed.Additionally, as a part of abbott¿s post-market surveillance process, all risk evaluations with associated complaint data are reviewed annually to determine if the risk profiles have changed as compared to the product risk management reports.These monitoring processes ensure that all product risk profiles remain acceptable and have a positive benefit/ risk ratio.At this time product has not yet been returned for this complaint.An extended investigation has been performed for the reported complaint.The dhr for the libre sensor and sensor kit indicated by the serial number provided by the customer was reviewed.The dhrs showed the libre sensor and sensor kits passed all tests prior to release and there was no indication that the product did not meet specifications.If the product is returned, the case will be re-opened, and a physical investigation will be performed.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 Key17741237
MDR Text Key323349213
Report Number2954323-2023-40397
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeKU
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 12/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number71992-01
Device Lot Number2.8.4.9335
Was Device Available for Evaluation? No
Date Manufacturer Received12/05/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/04/2023
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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