MAUDE Adverse Event Report: ABBOTT LABORATORIES FREESTYLE LIBRE SENSOR KIT 14 DAYS ; SENSOR, GLUCOSE, INVASIVE

Lot Number 191129P

Device Problems Defective Component (2292); Mechanics Altered (2984)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/19/2020

Event Type  malfunction  

Event Description

Pt reports that the filament is not a filament but a rigid needle - thicker and longer than normal filaments, not flexible.Fda safety report id# (b)(4).

• Brand Name: FREESTYLE LIBRE SENSOR KIT 14 DAYS
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT LABORATORIES
• MDR Report Key: 9744687
• MDR Text Key: 180890312
• Report Number: MW5093211
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2020
• Device Lot Number: 191129P
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 97