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

Model Number 71940-01

Device Problem No Display/Image (1183)

Patient Problems Fainting (1847); Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 01/03/2019

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 medical event during the "warm-up" period after the insertion of the adc freestyle libre sensor.On (b)(6) 2019, the customer experienced symptoms of hypoglycemia, fainted, lost consciousness and suffered a head injury.The customer was observed in the emergency and had an mri, nucleons test, and x-ray performed.The customer received a diagnosis of hypoglycemia but there is no report of treatment.The customer was hospitalized from (b)(6) 2019.There is no report that the customer received any immediate treatment for the hypoglycemia.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

No product has been returned and a valid serial number has not been provided for the reader and sensor.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.The device history record (dhr) for the libre reader were reviewed and the dhr showed the libre reader passed all tests prior to release.Clinical data was reviewed and confirmed that freestyle libre sensors continue to be safe, effective, and perform as intended in the field.A tripped trend review was conducted for the reported complaint and libre reader, no trends were identified that would indicate any product related issues.A tripped trend review was conducted for the reported complaint and libre sensor, no trends were identified that would indicate any product related issues.If the product is returned, the case will be re-opened, and a physical investigation will be performed.

Event Description

A customer reported a medical event during the "warm-up" period after the insertion of the adc freestyle libre sensor.On (b)(6)2019, the customer experienced symptoms of hypoglycemia, fainted, lost consciousness and suffered a head injury.The customer was observed in the emergency and had an mri, nucleons test, and x-ray performed.The customer received a diagnosis of hypoglycemia but there is no report of treatment.The customer was hospitalized from (b)(6)2019 to (b)(6)2019.There is no report that the customer received any immediate treatment for the hypoglycemia.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: devin dirstine ; 1360 south loop road; alameda, CA 94502-7001 ; 5108644391
• MDR Report Key: 8439070
• MDR Text Key: 139408823
• Report Number: 2954323-2019-02331
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• 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?: No
• Date Manufacturer Received: 01/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2019
• 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: 67 YR
• Patient Weight: 68