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

Model Number FREESTYLE LIBRE 14 DAY

Device Problem Activation Failure (3270)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/05/2021

Event Type  malfunction  

Event Description

Attempted to install freestyle libre 14 day monitor to canine, applicator failed to deploy sensor, it appear the needle became dislodged with the sensor, removed the sensor and the whole assembly came apart, the filament was still in the applicator needle assembly and the filament separated from the sensor electrical board.Removal caused bleeding requiring first aid.Fda safety report id # (b)(4).

• Brand Name: FREESTYLE LIBRE 14 DAY
• Type of Device: SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED
• Manufacturer (Section D): ABBOTT DIABETES CARE LIMITED
• MDR Report Key: 12137335
• MDR Text Key: 260803924
• Report Number: MW5102376
• Device Sequence Number: 1
• Product Code: PZE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 07/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2021
• Device Model Number: FREESTYLE LIBRE 14 DAY
• Device Catalogue Number: 71940-01
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 12 YR
• Patient Weight: 29