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

Model Number 71940-01

Device Problem Low Readings (2460)

Patient Problems Hyperglycemia (1905); Loss of consciousness (2418); Sweating (2444); Palpitations (2467)

Event Date 03/17/2019

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.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 customer reported a low readings issue with her adc freestyle libre sensor, stating that the sensor gave erroneous values indicating hypoglycemia.The customer experienced perspiration, palpitations, and lost consciousness.The customer ate "3 sugars" and some bread with honey, and a friend of the customer prepared pasta.The paramedics were called and it was further reported that a sensor scan reading of 96 mg/dl was compared to a reading of 197 mg/dl on the paramedic's meter.The paramedics administered 4 units of novorapid insulin as treatment.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Sensor (b)(4) has been returned and investigated.Visual inspection has been performed and no issues were observed.Extracted data from returned sensor using approved software.Sensor found to be in state 5 (indicating normal termination).The sensor plug was properly seated in the mount.Removed the sensor plug and inspected the plug assembly, no failure mode observed.Sensor was reprogrammed and current was applied to perform linearity testing while in the test fixture.All results were within specification.No malfunction or product deficiency was identified.This serves as a correction report.

Event Description

A customer reported a low readings issue with her adc freestyle libre sensor, stating that the sensor gave erroneous values indicating hypoglycemia.The customer experienced perspiration, palpitations, and lost consciousness.The customer ate "3 sugars" and some bread with honey, and a friend of the customer prepared pasta.The paramedics were called and it was further reported that a sensor scan reading of 96 mg/dl was compared to a reading of 197 mg/dl on the paramedic's meter.The paramedics administered 4 units of novorapid insulin as treatment.There was no report of death or permanent impairment 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: devin dirstine ; 1360 south loop road; alameda, CA 94502-7001 ; 5108644391
• MDR Report Key: 8500883
• MDR Text Key: 141504395
• Report Number: 2954323-2019-02910
• 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,Followup
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Date Manufacturer Received: 06/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2018
• 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): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 86