MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 2; SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED

Lot Number 6826980

Device Problems Component Missing (2306); Charging Problem (2892); Device-Device Incompatibility (2919); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2022

Event Type  malfunction  

Event Description

Reporter calling stating that her husband has had problems with the abbott freestyle libre 14-day sensor.He was unable to apply the sensor to his arm because the needle was bent and as such it could not be used.They contacted abbott about this issue and abbott provided a new freestyle libre, however they sent a freestyle libre 2, and the libre 2 was incompatible with their glucose reader.In addition, reporter states that abbott had never provided them an appropriate usb charging cable for their reader; they have been using other usb cables to charge the reader but they plan to contact abbott to have an appropriate charging cable sent to them.Ref reports: mw5117046, mw5117048.

• Brand Name: FREESTYLE LIBRE 2
• Type of Device: SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 16817060
• MDR Text Key: 314130414
• Report Number: MW5117047
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2023
• Device Lot Number: 6826980
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White