MAUDE Adverse Event Report: ABBOTT DIABETES CARE LTD FREESTYLE LIBRE 3; CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number 72081-01

Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/05/2024

Event Type  Death  

Event Description

Abbott diabetes care (adc) was notified of a customer, who was pregnant, who reported receiving a "replace sensor" message from the adc device.On (b)(6) 2024, the customer lost consciousness while sleeping, which was reported to have resulted in a "fall out of bed".After an hour and a half, the customer's spouse "woke [them] up" and provided treatment of tea and pastry.The customer then returned to bed and went back to sleep.It was additionally reported that on (b)(6) 2024, the customer suspected that the fetus was "not moving" and presented to the emergency room where it was determined that the fetus had no heart beat and had died at 26 weeks, resulting in a miscarriage.The exact date of fetal death is unknown.The customer reported that the suspected cause of miscarriage was strangulation by the umbilical cord.However, no autopsy report or death certificate has been provided at this time.The customer underwent induced labor and did not receive any diabetes-related treatment during this time.It is unknown if the customer had continued to wear the adc sensor in question, from the time of reported incident on (b)(6) 2024 until presenting to the emergency room on (b)(6) 2024.Additionally, it is unknown to adc when the fetal death occurred relative to the reported sensor error and resulting loss of consciousness.Given the limited information available to adc at this time, adc cannot draw any conclusions in regards to whether the adc device caused or contributed to the reported fetal death.A follow-up report will be sent if adc obtains any additional information regarding this event.

Manufacturer Narrative

At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The device history records (dhrs) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor and sensor kit passed all tests prior to release.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.It was indicated by the customer that the return of the device in question to the manufacturer has been initiated.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The exact date of fetal death is unknown.The date entered in b2 and b3 is the date that the customer was notified the fetus was deceased.Please note that the same product issue and event which occurred on (b)(6) 2024 was previously reported under adc reference (b)(4) / 2954323-2024-08134 on 08 mar 2024.However, at that time, the fetal death had not yet been reported to adc.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREESTYLE LIBRE 3
• Type of Device: CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE LTD; range road; witney 12345 -700; UK 12345-7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda 94502-7001 ; 5107495297
• MDR Report Key: 18946997
• MDR Text Key: 338184358
• Report Number: 2954323-2024-09432
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 35021791003373
• UDI-Public: (01)35021791003373(17)2024-07-31(10)T60001158(91)72115-01
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K212132
• 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
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 72081-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death