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

Model Number 71940

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Insufficient Information (4580)

Event Date 10/07/2021

Event Type  malfunction  

Event Description

Libre sensor from abbott blood glucose reading read 48.Blood glucose meter and finger stick read 105.Variance of 57 points.Completely unacceptable.Upon contacting abbott libre help line (b)(6), i was informed that abbott does not guarantee their libre sensors to work correctly on any given sensor.I was informed that in order to verify the correct readings for the libre sensor, that i should take my blood glucose reading the old-fashioned way by a finger stick.It is ridiculous that abbott expects their consumers to take finger sticks with another system in order to verify the accuracy of their libre sensor.Take the sensor off of the market! it is not reliable! even abbott does not guarantee that their product will work.Inaccurate blood glucose monitoring can become a life or death situation.Fda safety report id# (b)(4).

• Brand Name: FREESTYLE LIBRE SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE, INC.
• MDR Report Key: 12624387
• MDR Text Key: 276462268
• Report Number: MW5104558
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00357599001018
• UDI-Public: (01)00357599001018
• 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: 10/07/2021

1 Device was Involved in the Event

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: 03/31/2022
• Device Model Number: 71940
• Device Catalogue Number: 71940
• Device Lot Number: 210727Q
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 122