MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 2; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE

Patient Problem Needle Stick/Puncture (2462)

Event Date 09/08/2023

Event Type  Injury  

Event Description

I was starting a new continuous glucose monitor and as i pulled the applicator off the metal tube with a barb on it was stuck in my skin.I had to get help to have it removed.I have alerted you before about the issues with the freestyle libre and they have continued to get worse.Half the time they don't work and now i got a chunk of metal stuck in me.The company doesn't seem to care when i talk to them about it.

• Brand Name: FREESTYLE LIBRE 2
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 17745574
• MDR Text Key: 323575940
• Report Number: MW5145624
• Device Sequence Number: 1
• Product Code: QLG
• 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: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: BLOOD PRESSURE MEDICINE.; CONTINUOUS GLUCOSE MONITORING.; INSULIN.; MULTIVITAMIN.
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White