MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 3 SENSORS; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED

Lot Number T60001343

Patient Problems Bruise/Contusion (1754); Erythema (1840)

Event Date 01/30/2024

Event Type  malfunction  

Event Description

Abbott freestyle libre3 - quality issue: received 7 freestyle3 sensors that are defective.Unable to unscrew the cap from any of the 7 sensors.They seem to be permanently sealed.My wife and i spent hours trying to open one to apply to my skin.Our hands are red and raw from trying to unscrew the caps.We've had one of the sensors since october 2023 and just opened it last night - but were unable to open and apply it to my skin.Today, i called my md and asked for a refill.I picked up 6 more from the pharmacy this evening.We called abbott customer service, and from our conversation, it seems this was not the first time they heard about a problem with opening these sensors.We've had one of the sensors since october and picked up 6 more from the pharmacy this evening.They asked for all the serial numbers of the sensors, and we provided them.Reference reports: mw5150974, mw5150975, mw5150976, mw5150977, mw5150978, mw5150979.

• Brand Name: FREESTYLE LIBRE 3 SENSORS
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 18629249
• MDR Text Key: 334568118
• Report Number: MW5150980
• Device Sequence Number: 1
• Product Code: QLG
• 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: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 04/30/2024
• Device Lot Number: T60001343
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: HUMALOG.; LANTUS.
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic