MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 14 DAY; SENSOR, GLUCOSE, INVASIVE

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Defective Device (2588)

Patient Problem Hyperglycemia (1905)

Event Date 04/17/2020

Event Type  malfunction  

Event Description

Incorrect insulin dose.I recently started using the freestyle libre 14 day glucose monitor.Two of the first 4 sensors were defective as determined by abbott.Abbot replaced them.I have spent hours on the phone with abbott and the problem is on their end.Glucose readings on this monitor are significantly lower than readings using the standard finger stick meter.The problem of low readings on the glucose monitor is widely reported on the internet.It was also reported to me by my diabetic supplies company.The low readings cause an incorrect insulin dosage (too little insulin) resulting in higher than desired blood sugar levels.At this point, this system should not be used for insulin dosing.Fda safety report id#: (b)(4).

• Brand Name: FREESTYLE LIBRE 14 DAY
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 9987350
• MDR Text Key: 188973851
• Report Number: MW5094228
• Device Sequence Number: 1
• 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: 04/20/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 129