MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71953-01

Device Problem Device Alarm System (1012)

Patient Problems Hyperglycemia (1905); Loss of consciousness (2418)

Event Date 03/04/2024

Event Type  Injury  

Event Description

An alarm issue was reported with the adc device.The high and low glucose alarm did not sound, and customer was unaware of changes in glucose levels.As a result, customer experienced a loss of consciousness and was unable to self-treat.The customer had contact with a healthcare professional (hcp) who administered insulin (dose/type unspecified) and obtained an unspecified glucose reading for treatment.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

The most probable root causes associated with this failure mode are disconnected, faulty or damaged components, software/data corruption, or misuse.However, mitigations are in place to reduce and prevent such issues.All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.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.The product has been requested back for an investigation.At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.The dhrs (device history review) for the freestyle libre reader were reviewed and the dhrs showed the freestyle libre reader passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The date of event is unknown.The date entered in section b3 is the date reported to abbott diabetes care as "last week, specific time and date not avb".All pertinent information available to abbott diabetes care has been submitted.

Manufacturer Narrative

Reader (b)(6) has been returned and investigated.Visual inspection was performed on the returned reader; no issues were observed.The isf (interstitial fluid) log was downloaded using approved software.An analysis of the glucose value graph was performed and all alarms presented were for glucose values outside of the threshold range.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.

Event Description

An alarm issue was reported with the adc device.The high and low glucose alarm did not sound, and customer was unaware of changes in glucose levels.As a result, customer experienced a loss of consciousness and was unable to self-treat.The customer had contact with a healthcare professional (hcp) who administered insulin (dose/type unspecified) and obtained an unspecified glucose reading for treatment.There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE LIBRE 2
• Type of Device: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda 94502-7001 ; 5107495297
• MDR Report Key: 18977465
• MDR Text Key: 338561484
• Report Number: 2954323-2024-09953
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 05021791002832
• UDI-Public: (01)05021791002832(10)03D202F(91)71973-01
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K193371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/27/2024

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 Number: 71953-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 05/11/2024
• Supplement Dates FDA Received: 05/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention