MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71992-01

Device Problem Low Readings (2460)

Patient Problems Pain (1994); Urinary Frequency (2275); Diabetic Ketoacidosis (2364); Polydipsia (2604)

Event Date 02/01/2023

Event Type  Injury  

Event Description

Abbott diabetes care received an ansm declaration which reported the following information: a healthcare professional reported a lower sensor reading with the adc device.It was reported that the customer's sensor was reading 150 mg/dl in the morning, and the customer developed symptom of pain.A glucose result of 200 mg/dl was reported at onset of customer's symptoms (unknown device) and the customer called paramedics.A glucose result of 300 mg/dl was obtained, along with a result of 400 mg/dl upon arrival at hospital.The paramedics noted symptoms of polyuria, polydipsia, asthenia, and ketonic breath.The customer was diagnosed with diabetic ketoacidosis at hospital, and administered insulin (dose/type unknown), and hospitalized for unspecified duration.The reporter was contacted and indicated that they did not have further details, and the sensor in question had been discarded.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

The reported product is not expected to be returned as the device was reportedly discarded.A valid serial number has not been provided.An extended investigation has been performed for the reported complaint, and there was no indication that the product did not meet specification.Clinical data was reviewed and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field.Stability data for libre sensors was reviewed and showed no anomalies or non-conformances that could have lead to the complaint.A tripped trend review was conducted for the reported complaint and freestyle libre sensors; no trends were identified that would indicate any product related issues.In the event that unanticipated product is received, a physical investigation will be performed per adc's established processes and procedures and a follow-up report will be submitted upon completion of investigation.The device manufacturing date is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREESTYLE LIBRE 2
• Type of Device: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 16708161
• MDR Text Key: 312964696
• Report Number: 2954323-2023-14066
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K193371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention