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

Model Number 71940-01

Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)

Patient Problems Fainting (1847); Headache (1880); Hypoglycemia (1912); Sweating (2444)

Event Date 09/26/2020

Event Type  Injury  

Manufacturer Narrative

The sensor has been received and a physical investigation is pending at this time.A follow-up report will be submitted upon the investigation completion.All pertinent information available to abbott diabetes care has been submitted.

Event Description

The customer reported receiving a "replace sensor" error message after 4 days of wearing the adc freestyle libre sensor.The customer experienced symptoms described as feeling faint, sweating, and headache, and was unable to self-treat.The customer was treated with lucozade (energy drink) by a non-healthcare professional, and no further information was provided.There was no report of death or permanent impairment associated with this event.

Event Description

The customer reported receiving a "replace sensor" error message after 4 days of wearing the adc freestyle libre sensor.The customer experienced symptoms described as feeling faint, sweating, and headache, and was unable to self-treat.The customer was treated with lucozade (energy drink) by a non-healthcare professional, and no further information was provided.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Sensor (b)(4) has been returned and investigated.Visual inspection was performed and no issues were observed.Extracted data from returned sensor using approved software.Sensor was found to be in state 5 (indicating normal termination).The sensor plug was properly seated in the mount.The sensor plug was removed and the plug assembly was inspected, no issue observed.Sensor was reprogrammed and sim vivo (simulation of the electrical signal produced by the sensor tail) test was performed.All results were within specification.No malfunction or product deficiency was identified.Extended investigation has also been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs (device history review) 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.

• 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: 10663360
• MDR Text Key: 211006838
• Report Number: 2954323-2020-07046
• 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: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2021
• Device Model Number: 71940-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 70