MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 14 DAY; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71940-01

Device Problems Low Readings (2460); Appropriate Term/Code Not Available (3191)

Patient Problems Fatigue (1849); Skin Irritation (2076); Vomiting (2144); Cramp(s) (2193); Diabetic Ketoacidosis (2364); Loss of consciousness (2418)

Event Date 05/06/2019

Event Type  Injury  

Manufacturer Narrative

At this time product has not yet been returned and 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.The reported complaint is related to low readings and skin irritation or an allergic reaction to the patch adhesive of the freestyle libre sensor.Dose audit reports were reviewed and demonstrated the continued effectiveness of the established sterilization process for libre sensor products.Environmental monitoring reports were reviewed, including bioburden and endotoxin testing, and demonstrated that all monitoring processes continue to meet adc minimum requirements for product quality.Clinical data was reviewed and confirmed that freestyle libre sensor continue to be safe, effective, and perform as intended in the field.Clinical data was reviewed and confirmed that freestyle libre sensors continue to be safe, effective, and perform as intended in the field.Stability data for freestyle 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.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The device mfg 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.

Event Description

A low readings issue and a skin reaction was reported with use of the freestyle libre sensor.Customer reported she began receiving 'lo' (reading < 2.2 mmol/l) scan results on (b)(6) 2019 and experiencing symptoms described as tired, vomiting, and muscle cramps.Customer presumed she had the flu and continued to test using the sensor, and no comparison glucose tests were performed.On (b)(6) 2019, customer's symptoms persisted and her mother treated her with 2 units of insulin, popsicles, and water, however customer could not keep the items down and experienced a loss of consciousness.Paramedics were called and upon their arrival, a glucose result of 35 mmol/l was obtained on their device and compared to a sensor scan result of 9 mmol/l.Customer was transported to a hospital where she was diagnosed with diabetic ketoacidosis (dka) and administered "10-12 bags" of intravenous treatment.While in the hospital, a skin reaction at the sensor site was observed and customer was provided unspecified cream and dressing to help heal the sensor site.Customer remained hospitalized for five days.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE LIBRE 14 DAY
• Type of Device: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: tara williamson ; 1360 south loop road; alameda, CA 94502-7001 ; 5108644472
• MDR Report Key: 10515888
• MDR Text Key: 206484858
• Report Number: 2954323-2020-06134
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• PMA/PMN Number: P160030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71940-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 22 YR
• Patient Weight: 84