MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 14 DAY; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71940-01

Device Problem Material Twisted/Bent (2981)

Patient Problems Shaking/Tremors (2515); Convulsion/Seizure (4406)

Event Date 03/05/2021

Event Type  Injury  

Manufacturer Narrative

At this time product has not yet been returned.An extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specification.Dhrs (device history review) for the freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor kit passed all tests prior to release.Dose audit reports were reviewed and demonstrates the continued effectiveness of the established sterilization process for libre sensor products.Environmental monitoring reports were reviewed, including bioburden and endotoxin testing, and demonstrated that all monitoring processes continue to meet adc minimum requirements for product quality.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

A caregiver reported that upon the customer applying the adc freestyle libre sensor, it was noticed that sensor has a bent inserter needle therefore, the sensor could not be applied.The customer experienced symptoms described as ¿shaking hands, pallor, lethargy, swarthy skin and purple lips¿ and a seizure.It was further reported the customer was able to come to themselves and self-treated with glucose gel and then lispro sanofi (insulin) as treatment.No further treatment was reported.There was no report of death or permanent injury associated with this event.

Event Description

A caregiver reported that upon the customer applying the adc freestyle libre sensor, it was noticed that sensor has a bent inserter needle therefore, the sensor could not be applied.The customer experienced symptoms described as ¿shaking hands, pallor, lethargy, swarthy skin and purple lips¿ and a seizure.It was further reported the customer was able to come to themselves and self-treated with glucose gel and then lispro sanofi (insulin) as treatment.No further treatment was reported.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Sensor 0m0065ag9jh has been returned and investigated.Visual inspection was performed on the sensor and applicator, no issues were observed.The applicator had fired correctly.The applicator was pried open and the sharp was inspected, no issues were observed.Damaged transition features were, however, observed on the sensor pack.The sensor plug was properly seated in the mount.The sensor plug was removed and the plug assembly was inspected, no issues observed.No malfunction or product deficiency was identified, therefore this complaint is not confirmed to use due to incorrect assembly.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREESTYLE LIBRE 14 DAY
• 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: 11529316
• MDR Text Key: 241053897
• Report Number: 2954323-2021-51711
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• PMA/PMN Number: P160030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 06/08/2021

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: 03/31/2022
• Device Model Number: 71940-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2021
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 03/19/2021
• Supplement Dates Manufacturer Received: 05/20/2021
• Supplement Dates FDA Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 78