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

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Calibration Problem (2890)

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

Event Date 02/11/2020

Event Type  Injury  

Event Description

As user of freestyle libre 14 day cgm for 1+ years, recently since (b)(6) 2019 noticing 20-35 mg/dl error in comparison to ref lab and test strips.This has been noticed with latest replacement sensors sent by company by fedex and despite trouble shooting with their technical support staff - all guidelines were met.In past error 1 year ago had been less +/- 10 mg/dl.Yesterday (b)(6) 2020 in fasting sugar as measured in a sutter health, palo alto lab serum was 121 mg/dl while freestyle libre gave 94 reading as measured several times within 1 - 5 mins of blood draw.One touch ultra test strips in contrast was 123 well in tight range.This is unacceptable about 23% off.I have experienced similarly off readings repeatedly been on call on nearly every 14 days sensor 2 in december, 2 in january and ow, this is the latest replacement one sent by them applied (b)(6) 2020.It seems company is shipping sensors that are not calibrated or out of whack.The above is the ref test range.Freestyle libre 14 day gave 94 reading within 1 and 5 mins of blood draw.Multiple lots (b)(6) 2019 - (b)(6) 2020.Fda safety report id# (b)(4).

• Brand Name: FREESTYLE LIBRE SENSOR KIT AND READER 14 DAY
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE, INC.
• MDR Report Key: 9720617
• MDR Text Key: 180099544
• Report Number: MW5093019
• Device Sequence Number: 4
• 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: 02/12/2020
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 74