MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 14 DAY; SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED

Device Problems Break (1069); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Code Available (3191)

Event Date 06/13/2020

Event Type  Injury  

Event Description

Abbott freestyle libre 14 day system.The system reader stopped working, i called the 800 number, and the rep took my information and stated they would send a replacement.On today i called again because i had not received a replacement.The rep saw where i had called in, but could not verify if (b)(6) had delivered because the don't give them a tracking number.The lady said she would overnight a new reader, but could not give me a tracking number.I'm having trouble keeping my blood sugars in line.Sounds like a scam, when the company says (b)(6) won't supply a tracking number.She told me my case number is (b)(4).Is there anything you can do to help me? (b)(4).

• Brand Name: FREESTYLE LIBRE 14 DAY
• Type of Device: SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 10179791
• MDR Text Key: 196151049
• Report Number: MW5095131
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 68 YR
• Patient Weight: 102