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

Device Problems Material Protrusion/Extrusion (2979); Sharp Edges (4013)

Patient Problems Hemorrhage/Bleeding (1888); Inflammation (1932); Pain (1994)

Event Date 09/01/2022

Event Type  Injury  

Event Description

Used abbott free style 2 diabetes test system for over a year.About a month ago when installing sensor with my rn an unusual sharp pain occurred.A blue piece of plastic was found sticking out of a hole of the attached sensor.The pain increased, blood flowed, gripping the blue plastic a large needle was removed.The needle was saved, pictures were taken of needle pre and post removal.All items have been preserved for your exam if needed.The sensor was removed.The wound was bleeding, painful with surrounding tissues raised.Site was cleaned, bleeding stopped.Pain persisted for over a week, with residual reduced pain, exacerbated with raising of upper arm.Multiple attempts to contact abbott lab over a week resulted in conversations in many countries such as the philippines with the attempt to speak with someone who could do the following: explain what happened , provide insight or assistance to reduce pain.Etc.Only the same basic question, no answers just a mention that they would replace the sensor.I have hundreds of dollars in sensors i purchased, each works for 14 days that i am now afraid to use.Abbott has not responded by phone, email or usps.I have pictures of the wound site etc.I am not seeking fame but help and understanding, am i the only one this has happened to.Fda safety report id# (b)(4).

• Brand Name: FREESTYLE LIBRE 2
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR US
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 15503141
• MDR Text Key: 300897138
• Report Number: MW5112322
• 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: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 02/28/2023
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ALLOPURINOL; CLOPIDOGREL ; COQ10; FINASTERIDE; FUROSEMIDE; KETOCONAZOLE; LIPITOR; MAGNESIUM OXIDE; METOPROLOL; MONTELUKAST; MYRBETRIZ; PANTOPRAZOLE SODIUM; SPIRONOLACTONE; TRADJENTA; VALSARTAN
• Patient Outcome(s): Disability; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White