MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREE STYLE LIBRE 14 DAYS SENSOR ABBOTT; SENSOR, GLUCOSE, INVASIVE

Device Problem Low Readings (2460)

Patient Problem Hyperglycemia (1905)

Event Date 11/06/2020

Event Type  malfunction  

Event Description

Libre free style 14 days sensor repeatedly showed low sugar not responding to po large amount sugar intake.Finally bought accuchek and blood sugar was in 160-180 mg/dl.The next 2 sensors were also showing lower sugar by 40 mg than with blood sugar accucheks.The whole batch if 6 sensors are defective.New sensor from different batch is correctly showing sugar.This was notified to abbott free style 3 times in past and again today after realizing that whole batch is defective.Therapy date: (b)(6) 2020.Fda safety report id# (b)(4).

• Brand Name: FREE STYLE LIBRE 14 DAYS SENSOR ABBOTT
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 10975652
• MDR Text Key: 220689756
• Report Number: MW5098259
• Device Sequence Number: 3
• Product Code: MDS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/04/2020
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• 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 Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 64