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

Model Number 71940-01

Device Problem High Readings (2459)

Patient Problems Fainting (1847); Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 04/03/2019

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 in section 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 receiving a higher reading while wearing the adc freestyle libre sensor compared to a competitors brand meter.The customer reported a sensor scan of 81 mg/dl and subsequently fainted and lost consciousness.Upon paramedics arrival, a blood glucose of 43 mg/dl was obtained on the paramedic's meter and the customer was treated with "glucose strips." there was no report of death or permanent injury associated with this event.

Event Description

A customer reported receiving a higher reading while wearing the adc freestyle libre sensor compared to a competitors brand meter.The customer reported a sensor scan of 81 mg/dl and subsequently fainted and lost consciousness.Upon paramedics arrival, a blood glucose of 43 mg/dl was obtained on the paramedic's meter and the customer was treated with "glucose strips." 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 performed.

• 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: 8566958
• MDR Text Key: 143665262
• Report Number: 2954323-2019-03491
• 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: 01/21/2020

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: 04/04/2019
• Initial Date FDA Received: 04/30/2019
• Supplement Dates Manufacturer Received: 01/20/2020
• Supplement Dates FDA Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 117