MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE SENSOR KIT 14 DAY; SENSOR, GLUCOSE, INVASIVE

Lot Number OK

Device Problem Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Date 07/10/2020

Event Type  malfunction  

Event Description

Needle bent and was never inserted to patient.

• Brand Name: FREESTYLE LIBRE SENSOR KIT 14 DAY
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 10295543
• MDR Text Key: 199742125
• Report Number: MW5095608
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 57599000101
• UDI-Public: 57599000101
• Combination Product (y/n): Y
• 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: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: OK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/17/2020
• Patient Sequence Number: 1
• Patient Age: 57 YR