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

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 04/17/2021

Event Type  malfunction  

Event Description

I picked up my freestyle libre sensor prescription from (b)(6) pharmacy, and they gave me a used box.I didn't notice it until i was home.Inside of the box was a used sensor (which has a needle exposed).I brought it back and showed the pharmacist, and he didn't show any concern.I could've been stuck by that needle.I thought there were systems in place to prevent things like that from happening.Fda safety report id # (b)(4).

• Brand Name: FREESTYLE LIBRE
• Type of Device: SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 11700598
• MDR Text Key: 246978067
• Report Number: MW5100890
• Device Sequence Number: 1
• Product Code: PZE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 102