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

Model Number 71525-01

Device Problem Display or Visual Feedback Problem (1184)

Patient Problems Hypoglycemia (1912); Seizures (2063); Vomiting (2144); Loss of consciousness (2418)

Event Date 02/28/2018

Event Type  Injury  

Manufacturer Narrative

The customer's product has been requested for investigation.A follow-up report will be filed once the product is returned or additional information is obtained.The actual date when the event occurred in unknown.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Customer reported her adc freestyle libre reader continuously cycled through the various functions without holding down any buttons.It was further reported that approximately 5-6 days prior to calling adc customer service on (b)(6) 2018 she became hypoglycemic, but could not perform a test due to the meter issue and subsequently experienced both a loss of consciousness and a seizure and was ¿foaming at the mouth¿.Customer¿s neighbor, who is a physician assisted her by performing a capillary test (no results provided), diagnosing her with hypoglycemia and administering a glucagon injection.Customer also vomited after receiving the glucagon injection.No further treatment was reported.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

The reported reader was returned and investigated.Visual inspection was performed and no issues were observed.A touchscreen test was conducted on the reader and zones functioned correctly.The reader powers on with insertion of strips and connection to pc is successful.The complaint is not confirmed.

Event Description

Customer reported her adc freestyle libre reader continuously cycled through the various functions without holding down any buttons.It was further reported that approximately 5-6 days prior to calling adc customer service on (b)(6) 2018 she became hypoglycemic, but could not perform a test due to the meter issue and subsequently experienced both a loss of consciousness and a seizure and was ¿foaming at the mouth¿.Customer¿s neighbor, who is a physician assisted her by performing a capillary test (no results provided), diagnosing her with hypoglycemia and administering a glucagon injection.Customer also vomited after receiving the glucagon injection.No further treatment was reported.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE LIBRE
• 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: 7383180
• MDR Text Key: 103910655
• Report Number: 2954323-2018-02500
• 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: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71525-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Date Manufacturer Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2017
• Is the Device Single Use?: No
• 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: 50 YR
• Patient Weight: 60