MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 14 DAY SENSOR/ READER; SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED

Catalog Number 71940-01

Device Problems Device Displays Incorrect Message (2591); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 04/22/2020

Event Type  malfunction  

Event Description

Freestyle libre sensor defect.The prescription for a twenty-eight day refill, (2 sensors) was filled at a (b)(6) neighborhood market on (b)(6) 2020.The first of which was placed on the evening of (b)(6) 2020.When scanned the meter gave an error code."no sensor detected".The problem was reported to the manufacturer, via telephone.Patient was advised to swap it out for the other one and send back the faulty sensor.Upon doing so, (according to included, package instructions), blood was immediately noticed to be draining from the center of the newly placed sensor.It was promptly removed and another call made to the manufacturer.Fda safety report id# (b)(4).

• Brand Name: FREESTYLE LIBRE 14 DAY SENSOR/ READER
• Type of Device: SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.; alameda CA 94502
• MDR Report Key: 9995109
• MDR Text Key: 189153908
• Report Number: MW5094252
• Device Sequence Number: 1
• Product Code: PZE
• 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: 04/22/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 71940-01
• Device Lot Number: 200205P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 109