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

Model Number 72081-01

Device Problem Low Readings (2460)

Patient Problems Hyperglycemia (1905); Tachycardia (2095); Shaking/Tremors (2515)

Event Date 02/24/2023

Event Type  Injury  

Event Description

A low reading issue was reported with the adc sensor.Customer received an unspecified low sensor scan result that was lower than what they felt.As a result, the customer experienced hyperglycemia with symptoms described as ¿panic attack¿, tremors, and tachycardia and was unable to self-treat.Customer was seen at medical facility where a laboratory blood glucose result of ¿510+ mg/dl¿ was obtained and intravenous fluids and 10 units of humalog insulin were administered for treatment.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint and determined that there was no indication that the product did not meet specification.The dhrs (device history record) for the libre sensor and sensor kit were reviewed, and the dhrs showed the libre sensor and sensor kit passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.No additional verbiage required here in relation to same/similar reporting but as usual populate as needed.All pertinent information available to abbott diabetes care has been submitted.

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 extracted successfully and analyzed, and multiple errors were observed near the end of the historical data.De-cased the sensor and performed visual inspection of the printed circuit board assembly (pcba) and no issues were observed.The returned battery has been measured and results were within specification.Placed sensor in pcba test fixture to perform smu testing, all test have been passed.Additional testing has been performed for this issue, and poise voltage and sensor thermistor testing were both within specification, indicating the sensor was providing accurate glucose readings.Therefore, this issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A low reading issue was reported with the adc sensor.Customer received an unspecified low sensor scan result that was lower than what they felt.As a result, the customer experienced hyperglycemia with symptoms described as ¿panic attack¿, tremors, and tachycardia and was unable to self-treat.Customer was seen at medical facility where a laboratory blood glucose result of ¿510+ mg/dl¿ was obtained and intravenous fluids and 10 units of humalog insulin were administered for treatment.There was no report of death or permanent impairment 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: 16527586
• MDR Text Key: 311128123
• Report Number: 2954323-2023-09842
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K213996
• 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: 09/22/2023

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 Expiration Date: 11/30/2023
• Device Model Number: 72081-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 02/24/2023
• Initial Date FDA Received: 03/13/2023
• Supplement Dates Manufacturer Received: 08/25/2023
• Supplement Dates FDA Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/26/2022
• 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