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

Model Number 71940-01

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Fall (1848); Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 02/19/2021

Event Type  Injury  

Manufacturer Narrative

At this time product has not yet been returned and a valid serial number has not been provided.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.A stability and clinical review has been conducted and has found no indication of any product stability performance issues or clinical performance issues 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.The date of event is unknown.The date entered is the date reported as "2 months 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 customer reported on social media that he obtained higher values while scanning the adc freestyle libre sensor compared to an hcp meter.The customer stated the sensor value was "off by about 3.0 mmol/l".The customer had unspecified hypoglycemic symptoms 2 months ago that resulted in a fall and loss of consciousness.The customer's wife called emergency services and upon arrival, a sensor scan of 4.0 mmol/l (72 mg/dl) was received compared to an hcp meter result of "low".No further information was reported.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
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 11734973
• MDR Text Key: 247661375
• Report Number: 2954323-2021-67594
• 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
• Report Date: 04/27/2021

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: 04/19/2021
• Initial Date FDA Received: 04/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention