MAUDE Adverse Event Report: ABBOTT DIABETES CARE, INC. ABBOTT FREESTYLE LIBRE CGM SENSOR; GLUCOSE SENSOR

Device Problems Device Slipped (1584); Defective Component (2292)

Patient Problem No Information (3190)

Event Date 06/23/2018

Event Type  malfunction  

Event Description

This issue involves abbott freestyle libre sensor.The sensors cost (b)(6) for a thirty day supply.My third sensor was defective and did not remain adhered to my skin.It came off on a saturday.The customer service line is only open monday-friday, which is inadequate for necessary health care products.Monday i telephoned again, after leaving three messages.Spoke to agent in (b)(6), offered a voucher which could be used at one of 5 pharmacies to replace sensor.But voucher requires a prescription from my doctor.I asked to have sensor shipped overnight.Was told they can ship over 5-7 days.I argued and repeated overnight shipping.I was told they would do this and i would receive them on tuesday, the next day.Today i called for tracking number and was told it takes them a day and a half to arrange shipment, then another day for shipment.This is absurd considering the over (b)(6) cost for this individual device that lasts only ten days, for continuous blood glucose monitoring.I request that the fda work with abbott to promote 24/7 customer service, and guarantee overnight delivery on vitally needed medical products.

• Brand Name: ABBOTT FREESTYLE LIBRE CGM SENSOR
• Type of Device: GLUCOSE SENSOR
• Manufacturer (Section D): ABBOTT DIABETES CARE, INC.
• MDR Report Key: 7645735
• MDR Text Key: 112749368
• Report Number: MW5078134
• Device Sequence Number: 1
• Product Code: MDS
• 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: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• 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 Age: 67 YR
• Patient Weight: 55