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); Palpitations (2467)

Event Date 11/09/2019

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 device mfg date is unknown.The date entered 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 reported receiving a sensor scan message of 'lo' (reading less than 40 mg/dl) and experiencing symptoms described as headache, sore neck, stomach pain, and heart palpitations.Customer had contact with a healthcare provider and was diagnosed with hyperglycemia and treated with insulin.Sensor scan results of 497 mg/dl and 402 mg/dl were reportedly compared to hcp meter results of 441 mg/dl and 342 mg/dl, however it is unknown when these readings were obtained in relation to the reported treatment.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

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, the case will be re-opened and a physical investigation will be performedthe serial number provided by the customer in the initial report was deemed invalid upon extended investigation and therefore section d4 has been updated to unk.

Event Description

A low readings issue was reported with the adc freestyle libre sensor.Customer reported receiving a sensor scan message of 'lo' (reading less than 40 mg/dl) and experiencing symptoms described as headache, sore neck, stomach pain, and heart palpitations.Customer had contact with a healthcare provider and was diagnosed with hyperglycemia and treated with insulin.Sensor scan results of 497 mg/dl and 402 mg/dl were reportedly compared to hcp meter results of 441 mg/dl and 342 mg/dl, however it is unknown when these readings were obtained in relation to the reported treatment.There was no report of death or permanent injury 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: 9438424
• MDR Text Key: 169865401
• Report Number: 2954323-2019-09629
• 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: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• 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
• Date Manufacturer Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 85