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

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Description

Wrong quantity of freestyle libre sensor dispensed to pt.(b)(4).Pt billed for 2 sensors and 28 day supply when received 1 sensor and 14 day supply.(b)(6).Phone: (b)(6) email: (b)(6).Submission id: (b)(4).

• Brand Name: FREESTYLE LIBRE SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 15799064
• MDR Text Key: 303727055
• Report Number: MW5113236
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1