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

Lot Number 02Z178D

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/30/2020

Event Type  No Answer Provided  

Event Description

Freestyle libre monitor has been giving consistently low readings of 114, and 120.Reporter states that she started to feel something was wrong her monitor on (b)(6) 2020; she has been underdosing or not administering corrective blood sugar doses due to inaccurate readings.She also, reports that two of her sensors didn't last the 14 days they fell off early.

• Brand Name: FREESTYLE LIBRE MONITOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 10419974
• MDR Text Key: 203524629
• Report Number: MW5096113
• Device Sequence Number: 2
• 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: 08/17/2020
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Device Operator: No Information
• Device Expiration Date: 09/30/2020
• Device Lot Number: 02Z178D
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other