MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREE STYLE LIBRE SENSORS; SENSOR, GLUCOSE, INVASIVE

Lot Number 2102060

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/17/2021

Event Type  malfunction  

Event Description

Five (5) of the freestyle libre sensors without needles.

• Brand Name: FREE STYLE LIBRE SENSORS
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 12075179
• MDR Text Key: 258913901
• Report Number: MW5102162
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 57599000101
• UDI-Public: 57599000101
• 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: 06/18/2021
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2021
• Device Lot Number: 2102060
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR