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

Model Number 71938-01

Device Problems Crack (1135); Unable to Obtain Readings (1516)

Patient Problems Diabetic Ketoacidosis (2364); Loss of consciousness (2418); Polydipsia (2604)

Event Date 09/30/2020

Event Type  Injury  

Manufacturer Narrative

At this time product has not yet been returned.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 dhrs (device history review) for the libre reader were reviewed and the dhrs showed the libre reader passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The exact date of event is unknown.The date entered is the based on the customer's report of "end of (b)(6) 2020." all pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported that he dropped the adc freestyle libre reader which subsequently cracked and damaged.The customer reported due to this he spent a month without monitoring his glucose levels, and eventually experienced symptoms described as "white tongue, very thirsty, difficulty speaking", vomiting, and loss of consciousness.An ambulance was called and customer was taken to the hospital where he underwent testing (urinary survey, ct scan, heart test) and received perfusion and unspecified treatment for a diagnosis of diabetic ketoacidosis.Additionally, it was reported that the customer had a change in insulin protocol.No further information was provided.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: erica frank ; 1360 south loop road; alameda, CA 94502-7001 ; 5104242454
• MDR Report Key: 11164988
• MDR Text Key: 226640764
• Report Number: 2954323-2021-00937
• 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
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71938-01
• Device Catalogue Number: 71938-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 43 YR
• Patient Weight: 73