MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC ABBOTT FREESTYLE LIBRE 10 DAY; SENSOR, GLUCOSE, INVASIVE

Device Problems Loose or Intermittent Connection (1371); Unable to Obtain Readings (1516); Detachment of Device or Device Component (2907)

Patient Problem Blood Loss (2597)

Event Date 02/11/2019

Event Type  malfunction  

Event Description

Bought an abbott freestyle libre 10 day device + 3 sensors.First time device wouldn¿t read ¿ the first sensor was ¿loose.¿ contacted manufacturer.Second sensor worked.3rd sensor did not go on the back of my arm ¿ used as directed.Sensor pack came off and needle caused bleed.Contacted manufacturer.No answers.Returned 2 sensors to the manufacturer.1st ¿loose sensor¿ and 3rd ¿caused bleeding sensor.¿.

• Brand Name: ABBOTT FREESTYLE LIBRE 10 DAY
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC
• MDR Report Key: 8343488
• MDR Text Key: 137057979
• Report Number: MW5084096
• Device Sequence Number: 2
• Product Code: MDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/12/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR