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

Model Number 71702-01

Device Problem Low Readings (2460)

Patient Problems Fainting (1847); Hyperglycemia (1905)

Event Date 01/02/2019

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 date of event is unknown.The date entered is the date abbott diabetes care became aware of the event.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 customer reported a lower scan while wearing the adc freestyle libre sensor compared to the hcp meter.The customer noted a scan of 4mmol/l compared to 25mmol/l on the hcp meter and stated that they fainted and received emergency treatment at the hospital.There was no report of death or permanent injury associated with this event.

Event Description

A customer reported a lower scan while wearing the adc freestyle libre sensor compared to the hcp meter.The customer noted a scan of 4 mmol/l compared to 25 mmol/l on the hcp meter and stated that they fainted and received emergency treatment at the hospital.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.The reported complaint does not pertain to the freestyle libre reader.Therefore no further investigation into the reader is required.Dhrs (device history review) for all fs libre sensors within expiration at the time of complaint were reviewed, and the dhr review showed no there were no deviations from the validated manufacturing process and no issues identified that could have led to the complaint.  clinical data was reviewed for the fs libre sensors, and confirmed that fs libre sensors continue to be safe, effective, and perform as intended in the field.    stability data for fs libre sensors was reviewed and showed no anomalies or non-conformances that could lead to the complaint.    a tripped trend review was completed for the reported complaint and fs libre sensors, no tripped trends were observed.  if the product is returned, the case will be re-opened and a physical investigation will be performed.

• Brand Name: FREESTYLE LIBRE
• 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: 8257778
• MDR Text Key: 133390864
• Report Number: 2954323-2019-00522
• 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: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71702-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention