MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE2; SENSOR, GLUCOSE, INVASIVE

Lot Number KTP002782

Device Problems Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/14/2022

Event Type  malfunction  

Event Description

Applied a new freestyle libre2 sensor for monitoring.Was cleaning up packaging and sensor fell off.Noticed that the needle was bent so did not insert properly when tried to apply sensor.Tried to apply another sensor this one stuck however there was bleeding at sensor site.While sitting in car the next afternoon this sensor fell off the arm.Waited until monday to use another sensor since insurance will not pay for additional sensors and prescription could not be refilled until end of (b)(6).As stated applied 3rd sensor on monday lunchtime.Was walking around dinner time and this sensor also fell off.Three sensors in 3 days to me indicates a problem.I've been using sensors for a number of years now so it's not like i am new to the process.Either the adhesive is bad or there is not enough adhesive to support sensor don't know but should not just fall off arm.Fda safety report id # (b)(4).

• Brand Name: FREESTYLE LIBRE2
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC
• MDR Report Key: 14513299
• MDR Text Key: 292970383
• Report Number: MW5109915
• 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: 05/20/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2022
• Device Lot Number: KTP002782
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/25/2022
• Patient Sequence Number: 1
• Treatment: ASPIRIN 81 G; ATORVASTIN; HUMALOGUE; MULTIVITAMIN; TRESIBA
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White