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

Model Number 72081-01

Device Problems Device Alarm System (1012); No Audible Alarm (1019)

Patient Problems Hypoglycemia (1912); Shaking/Tremors (2515); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 12/17/2022

Event Type  Injury  

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 mfg date is unknown.The date entered is the date abbott diabetes care became aware of the event.N/a was selected as it is unknown if the user was using android, ios, or a reader with the fs libre 3 sensor.All pertinent information available to abbott diabetes care has been submitted.

Event Description

An alarm issue was reported with the abbott diabetes care (adc) device.The low glucose alarm did not sound and customer was not alerted of changes in glucose level.As a result, the customer experienced "tremors", "cramps", and a seizure and was unable to self-treat.Customer received unspecified treatment by a non-healthcare professional and was seen at a hospital where they were treated with an unspecified infusion for a diagnosis of hypoglycemia.There was no report of death or permanent injury 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.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 libre sensor and libre sensor kits were reviewed and the dhrs showed the libre sensor and libre sensor kits passed all tests prior to release.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.

Event Description

An alarm issue was reported with the abbott diabetes care (adc) device.The low glucose alarm did not sound and customer was not alerted of changes in glucose level.As a result, the customer experienced "tremors", "cramps", and a seizure and was unable to self-treat.Customer received unspecified treatment by a non-healthcare professional and was seen at a hospital where they were treated with an unspecified infusion for a diagnosis of hypoglycemia.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.Visual inspection has been performed and no issues were observed on sensor patch.Data was downloaded successfully, sensor state 7 with event log 11 and sensor state 8 with event log 9 are an indication that the sensor had terminated due to an error recognized by the sensor.This is a part of software design and is not an indication of product non-conformance.De-cased the returned sensor and performed visual inspection of the printed circuit board assembly (pcba), observed that the molex connector and antenna had been damaged due to de-casing and is unable to be re-soldered/repaired due to the solder pads coming away from the pcba, pqe are unable to perform smu testing without the molex connector connected and antenna.Therefore, this issue is unable to test.Section h6 (investigation findings) code c20 (no findings available) and d15 casue not established was selected, as adc was unable to perform further testing on the returned device.All pertinent information available to abbott diabetes care has been submitted.

Event Description

An alarm issue was reported with the abbott diabetes care (adc) device.The low glucose alarm did not sound and customer was not alerted of changes in glucose level.As a result, the customer experienced "tremors", "cramps", and a seizure and was unable to self-treat.Customer received unspecified treatment by a non-healthcare professional and was seen at a hospital where they were treated with an unspecified infusion for a diagnosis of hypoglycemia.There was no report of death or permanent injury associated with this event.

• 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, CA 94502-7001 ; 5107495297
• MDR Report Key: 16067782
• MDR Text Key: 306331138
• Report Number: 2954323-2022-47510
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• 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,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2023
• Device Model Number: 72081-01
• Device Catalogue Number: 72081-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention