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

Model Number 71940-01

Device Problem High Readings (2459)

Patient Problems Hypoglycemia (1912); Weakness (2145); Sweating (2444); Palpitations (2467); Shaking/Tremors (2515)

Event Date 03/19/2020

Event Type  Injury  

Manufacturer Narrative

The reported product is not expected to be returned as reporter indicated she no longer has the equipment.A follow-up report will be filed if product is returned or 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 high readings issue was reported with the freestyle libre sensor.Customer reported being at the hospital for an issue unrelated to the use of the device when she experienced symptoms described as weakness, cold sweats, tremors, and palpitations.Customer obtained a sensor scan result of 93 mg/dl compared to a reading of 48 mg/dl obtained on the hcp meter.A nurse treated the customer with g30 glucose and customer was cleared to go home.Upon arriving home an hour later, customer experienced the same symptoms and obtained a sensor scan result of 95 mg/dl compared to a reading of 42 mg/dl obtained on an unspecified blood glucose device.Customer was treated by her husband with "sugars and sweets".No further treatment was reported.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

No product has been returned.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and sensor kit passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.

Event Description

A high readings issue was reported with the freestyle libre sensor.Customer reported being at the hospital for an issue unrelated to the use of the device when she experienced symptoms described as weakness, cold sweats, tremors, and palpitations.Customer obtained a sensor scan result of 93 mg/dl compared to a reading of 48 mg/dl obtained on the hcp meter.A nurse treated the customer with g30 glucose and customer was cleared to go home.Upon arriving home an hour later, customer experienced the same symptoms and obtained a sensor scan result of 95 mg/dl compared to a reading of 42 mg/dl obtained on an unspecified blood glucose device.Customer was treated by her husband with "sugars and sweets".No further treatment was reported.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
• MDR Report Key: 9878811
• MDR Text Key: 185904788
• Report Number: 2954323-2020-02310
• 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: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• 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: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Weight: 50