MAUDE Adverse Event Report: ABBOTT DIABETES CARE LIMITED FREESTYLE LIBRE FLASH GLUCOSE MONITORING SYSTEM; SENSOR, GLUCOSE, INVASIVE

Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)

Patient Problems Rash (2033); Fluid Discharge (2686)

Event Date 02/01/2020

Event Type  Injury  

Event Description

Reporter called to report that his last three sensor usage resulted in rash, oozing on his arm and sensor detachment.The reporter stated that he has called the manufacturer about the issues and they've responded by sending him one to replace the one that has detached and has advised him to see his doctor.Reporter states he is unable to visit the doctor at this time due to the stay at home order that is in place and that he has a health history that makes him high risk for covid-19.He has tried placing the sensors in the suggested places however, they continue to feel moist and began to loosen.

• Brand Name: FREESTYLE LIBRE FLASH GLUCOSE MONITORING SYSTEM
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE LIMITED
• MDR Report Key: 9934356
• MDR Text Key: 187066575
• Report Number: MW5094076
• Device Sequence Number: 2
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/07/2020
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Weight: 98