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

Device Problems Loss of or Failure to Bond (1068); Product Quality Problem (1506)

Patient Problems Cellulitis (1768); Erythema (1840); Inflammation (1932)

Event Date 07/01/2019

Event Type  Injury  

Event Description

Caller called to report that a pt has noticed a product quality change with her freestyle libre sensor.In (b)(6) this year the pt noticed that her sensor would not adhere as she had previously, she also noticed that the packaging had changed color and wondered if the effectiveness of the device had changed too.Reporter also, states that the pt developed redness and inflammation under her sensor with a diagnosis of cellulitis.

• Brand Name: FREESTYLE LIBRE
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 8949956
• MDR Text Key: 156344067
• Report Number: MW5089479
• Device Sequence Number: 1
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR