MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRELINK - US (SOFTWARE USED IN AN ANDROID CELLULAR PHONE); CONTINUOUS GLUCOSE MONITOR RETROSPECTIVE DATA ANALYSIS SOFTWARE

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Date 09/04/2019

Event Type  malfunction  

Event Description

The freestyle librelink - us android app stopped working with an update to android (b)(6).This prevents the testing of blood sugar levels using a phone as the device reader.Switching to a different type of reader is impossible with the existing sensor which requires that a new sensor be applied.If a different reader is not available, the sensor is not usable and blood sugar readings can be obtained via the freestyle libre which may result in serious diabetic blood sugar related problems.Fda safety report id# (b)(4).

• Brand Name: FREESTYLE LIBRELINK - US (SOFTWARE USED IN AN ANDROID CELLULAR PHONE)
• Type of Device: CONTINUOUS GLUCOSE MONITOR RETROSPECTIVE DATA ANALYSIS SOFTWARE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 8992417
• MDR Text Key: 158639215
• Report Number: MW5089709
• Device Sequence Number: 1
• Product Code: PHV
• 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: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/07/2019
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 68