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

Model Number 71992-01

Device Problem Device Alarm System (1012)

Patient Problems Hypoglycemia (1912); Sweating (2444); Confusion/ Disorientation (2553)

Event Date 10/08/2020

Event Type  Injury  

Manufacturer Narrative

Adc product quality engineering (pqe) investigated this alarm-2 (signal loss alarm) complaint.It was determined that the freestyle libre 2 sensor reported in this complaint was manufactured at flex buffalo grove (fbg) with the incorrect low temperature ratio parameter of zero (0).The low temperature ratio parameter setting should be set at 187.The incorrect low temperature ratio parameter will prevent the sensor bluetooth low-energy (ble) radio from enabling in the operational temperature range, and as a result the system will not be able to present glucose alarms.This failure mode was identified during investigation of the track and trend review related to alarm-2 cases in (b)(6) 2020.This issue was addressed in the field by adc fa1027-2020.Dhrs (device history review) 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 temperature ratio setting is in the machine software and therefore, not captured in the dhr.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

The customer reported a signal loss issue with the freestyle libre 2, which resulted in the low glucose alarm failing to trigger.The customer experienced symptoms of incoherent and sweating, and the sensor was reading 'lo' (< 40 mg/dl).The customer was treated with a glucose injection by his wife.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Sensor (b)(4) was returned and investigated.A visual inspection was performed on the returned sensor patch and sensor plug assembly, no issues were observed.Sensor data was extracted using approved software and found to be in sensor state 5 (indicating normal termination).It was identified that the low-temperature ratio parameter was configured incorrectly to zero (0).This issue is therefore confirmed.

Event Description

The customer reported a signal loss issue with the freestyle libre 2, which resulted in the low glucose alarm failing to trigger.The customer experienced symptoms of incoherent and sweating, and the sensor was reading 'lo' (40 mg/dl).The customer was treated with a glucose injection by his wife.There was no report of death or permanent injury 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 CA 94502 7001
• MDR Report Key: 10711683
• MDR Text Key: 212300210
• Report Number: 2954323-2020-07679
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• PMA/PMN Number: K193371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

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: 03/31/2021
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: 12/08/2020
• Supplement Dates FDA Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: QR728102
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR