MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE CONTINUOUS GLUCOSE MONITORING SENSORS; SENSOR, GLUCOSE, INVASIVE

Device Problems Break (1069); Material Twisted/Bent (2981)

Patient Problem Erythema (1840)

Event Date 08/03/2020

Event Type  malfunction  

Event Description

Started using freestyle libre cgm about 18 days ago; each sensor has fallen off even with tapes, iv tapes and bandages.One of the sensors left dime-size red mark and wire was bent.Contacted company each time.These sensors cost (b)(6) and although company has replaced one so far.They used fed ex which delivered to back door.Sat in 95-100 degree temps and rain storm for 2 days before being noticed at the back door (we don't use back door for delivery).(b)(6) replied not responsible for damages; freestyle libre notified.In 18 days, i've used 4 sensors.The adhesive on the back is not enough.Box should contain skin tac adhesives if they aren't sticking.Company said consumer has to buy additional products to make it stick so in the end, consumer/ patient has to buy skin prep, skin tac and the sensors which only last 14 days and most insurances do not cover the cost.Suggestion: if not changing the design, include skin tac or lower cost.If changing design, increase adhesive and the length of use and the ability to place on other parts of body besides just the back of the arm.I really like the reading of the sensor and not having to stick my finger and the way i can really watch my sugar levels and see what foods do and most importantly work on my average blood glucose levels.Although with it falling off all the time, it makes it difficult.Fda safety report id # (b)(4).

• Brand Name: FREESTYLE LIBRE CONTINUOUS GLUCOSE MONITORING SENSORS
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 10367335
• MDR Text Key: 202069056
• Report Number: MW5095894
• 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: 08/03/2020
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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 Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 93