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

Model Number 71940-01

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Hypoglycemia (1912); Seizures (2063); Palpitations (2467)

Event Date 08/06/2020

Event Type  Injury  

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 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

A caregiver reported the customer¿s adc freestyle libre sensor fell off after 6 days of wear and the customer experienced symptoms described as ¿convulsions, rapid heartbeat, pale skin, and seizure¿.The caregiver further reported a reading of 34 mg/dl was obtained on an unspecified device and the customer was unable to self-treat.A non-hcp administered glucose gel as treatment.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Sensor ((b)(6) ) has been returned and investigated.Visual inspection was performed on the returned sensor patch and the adhesive and no issues were observed.No malfunction or product deficiency was identified.Section d3 (email) and section g1 were updated to reflect current contact information.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A caregiver reported the customer¿s adc freestyle libre sensor fell off after 6 days of wear and the customer experienced symptoms described as ¿convulsions, rapid heartbeat, pale skin, and seizure¿.The caregiver further reported a reading of 34 mg/dl was obtained on an unspecified device and the customer was unable to self-treat.A non-hcp administered glucose gel as treatment.There was no report of death or permanent impairment associated with this event.

• 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: 10417960
• MDR Text Key: 203276245
• Report Number: 2954323-2020-05534
• 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: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2021
• Device Model Number: 71940-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention