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 Problem Hyperglycemia (1905)

Event Date 08/24/2016

Event Type  Injury  

Manufacturer Narrative

The reported product is not expected to be returned as reporter indicated the device was discarded.A follow-up report will be filed if product is returned or additional information is obtained.The date of event is unknown.The date entered is based on the report of "4 years ago".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 freestyle libre sensor.Customer reported that four years ago, she received low sensor scans and being hospitalized.No symptoms were reported, but in the hospital, customer was treated with glucose based on the sensor scan results received.Post-treatment of glucose, a reading of 350 mg/dl was obtained on the hcp meter compared to a sensor scan result of 60 mg/dl, and customer was administered insulin for treatment.No further details were provided.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, a physical investigation will be performed and a follow-up report submitted.

Event Description

A low readings issue was reported with the freestyle libre sensor.Customer reported that four years ago, she received low sensor scans and being hospitalized.No symptoms were reported, but in the hospital, customer was treated with glucose based on the sensor scan results received.Post-treatment of glucose, a reading of 350 mg/dl was obtained on the hcp meter compared to a sensor scan result of 60 mg/dl, and customer was administered insulin for treatment.No further details were provided.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: 10475037
• MDR Text Key: 205069363
• Report Number: 2954323-2020-05879
• 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: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• 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: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Weight: 110