MAUDE Adverse Event Report: ABBOTT DIABETES CARE LTD LIBREVIEW; FLASH GLUCOSE MONITORING SYSTEM

Model Number N/A

Device Problem Product Quality Problem (1506)

Patient Problems Loss of consciousness (2418); Shaking/Tremors (2515)

Event Date 06/18/2023

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 manufacturing date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

The customer reported not receiving a reset password email or email verification email with the adc device.The customer reported that they could not get into the application, so the readings were unavailable.The customer reported experiencing symptoms described as "shaking and passed out" and subsequently self-treated with orange juice.There was no report of death or permanent impairment associated with this event.

Event Description

The customer reported not receiving a reset password email or email verification email with the adc device.The customer reported that they could not get into the application, so the readings were unavailable.The customer reported experiencing symptoms described as "shaking and passed out" and subsequently self-treated with orange juice.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

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 user reported an issue with receiving a password reset email from libreview.This may occur if the email has been incorrectly identified as spam or a malicious message.Attempted to replicate the user¿s complaint using similar configuration and successfully received a password reset email from libreview.Unable to reproduce the customer complaint.Therefore, issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: LIBREVIEW
• Type of Device: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE LTD; range road; witney 12345 -700; UK 12345-7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 17339260
• MDR Text Key: 319178286
• Report Number: 2954323-2023-30819
• Device Sequence Number: 1
• Product Code: PHV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• 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: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other