MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 2 14-DAY SENSOR; SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED

Lot Number 220719Q

Device Problems Material Protrusion/Extrusion (2979); Sharp Edges (4013); Activation Problem (4042)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946); Pain (1994)

Event Date 09/08/2022

Event Type  Injury  

Event Description

Reporter calling to report an injury after applying her freestyle libre 2 sensor.She states she applied the sensor on her arm "last night" and "it hurt" when applied, which was unusual.She had difficulty scanning/activating the device, and that was when she noticed an "inch-long, needle-like projectile" sticking out from the sensor, on the insertion side of the device.Her arm was bleeding, and it was painful.She removed the sensor and cleaned her arm up.She saw her doctor on (b)(6) 2022 regarding her injury and was given a tetanus shot as a precaution.She has not contacted abbott regarding this event, however plans on doing so; she was urged by her physician to contact the fda first to report this matter.Reporter states she likes the freestyle libre system and finds it useful in the management of her diabetes.

• Brand Name: FREESTYLE LIBRE 2 14-DAY SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 15401901
• MDR Text Key: 299793968
• Report Number: MW5111974
• Device Sequence Number: 1
• Product Code: PZE
• 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: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2023
• Device Lot Number: 220719Q
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Treatment: TETANUS SHOT
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Female