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

Device Problem Defective Component (2292)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 02/10/2022

Event Type  Injury  

Event Description

Reporter states that they received their monthly supply of sensors and none of them worked.Tried to initiate the first five, and once he got to the six sensor, he was in extreme pain and discomfort.Reporter has notified the mfr of his defective sensors.

Event Description

Reporter states that they received their monthly supply of sensors and none of them worked.Tried to initiate the first five, and once he got to the six sensor, he was in extreme pain and discomfort.Reporter has notified the mfr of his defective sensors.

• Brand Name: FREESTYLE LIBRE SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE, INC.
• MDR Report Key: 13563390
• MDR Text Key: 285957635
• Report Number: MW5107588
• 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: Patient
• Type of Report: Initial
• Report Date: 02/17/2022
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Treatment: FREESTYLE LIBRE CGM
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 134 KG