MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 14-DAY FLASH GLUCOSE MONIITORING SYSTEM SENSOR; SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED

Catalog Number 71940-01

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 01/25/2021

Event Type  malfunction  

Event Description

Abbott labs freestyle libre 14 day continuous glucose monitoring sensor.They rarely last 14 days.I have had 3 fail in less than 14 days in (b)(6) 2021 alone.In the past year, i estimate at least 10 sensors failed.The two serial numbers of the last two to fail are (b)(4).I do not have the failed sensors as abbott requested they be sent back for them to study why they failed.Twice last year i was out of town and had sensors fail, leaving me with no way to check blood sugar until i returned home, which of course is dangerous.Fda safety report id# (b)(4).

• Brand Name: FREESTYLE LIBRE 14-DAY FLASH GLUCOSE MONIITORING SYSTEM SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 11243467
• MDR Text Key: 229837704
• Report Number: MW5099053
• Device Sequence Number: 3
• Product Code: PZE
• 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: 01/25/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 71940-01
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/27/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 110