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

Lot Number 180428R

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

Patient Problem No Information (3190)

Event Date 07/10/2018

Event Type  malfunction  

Event Description

Used new freestyle libre blood glucose compatable for 2 days then it began giving wrong blood levels.Changed sensor in product with new one took 12 hrs to activate; next morning it wouldn't read, was telling me to change sensor, put another sensor in read right for 4 days then started reading wrong again; stopped using it because of false readings.

• Brand Name: FREESTYLE LIBRE
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 7893198
• MDR Text Key: 121047355
• Report Number: MW5079920
• Device Sequence Number: 0
• 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: Other
• Type of Report: Initial
• Report Date: 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/31/2018
• Device Lot Number: 180428R
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 104