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

Model Number 71940-01

Device Problem Low Readings (2460)

Patient Problems Headache (1880); Hyperglycemia (1905); Polydipsia (2604)

Event Date 09/30/2021

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The date of event is unknown.The date entered in is the date abbott diabetes care became aware of the event.The device mfg date is unknown.The date entered in is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A low readings issue was reported with the adc freestyle libre sensor.Customer received unspecified low readings on the sensor and experienced "headache, weakness and excessive thirst".Customer self-treated with additional glucose gel based on sensor low reading; however, it intensified the symptoms.Customer was then treated with unspecified dose of insulin.No further information was provided.There was no report of death or permanent impairment associated with this event.

Event Description

A low readings issue was reported with the adc freestyle libre sensor.Customer received unspecified low readings on the sensor and experienced "headache, weakness and excessive thirst".Customer self-treated with additional glucose gel based on sensor low reading; however, it intensified the symptoms.Customer was then treated with unspecified dose of insulin.No further information was provided.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned and a valid serial number has not been provided.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Clinical data was reviewed and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field.Stability data for libre sensors was reviewed and showed no anomalies or non-conformances that could have lead to the complaint.A tripped trend review was conducted for the reported complaint and fs libre sensors, no trends were identified that would indicate any product related issues.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.Upon extended investigation, it was determined that the serial number provided by the customer (b)(6) and previously reported to the fda was not a valid serial number.Therefore, section d4 was updated to unk.

• 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: 12617189
• MDR Text Key: 275953506
• Report Number: 2954323-2021-88204
• 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: 10/27/2021

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 Model Number: 71940-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/30/2021
• Initial Date FDA Received: 10/12/2021
• Supplement Dates Manufacturer Received: 10/21/2021
• Supplement Dates FDA Received: 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention