MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE PRECISION NEO; BLOOD GLUCOSE MONITORING SYSTEM

Model Number 75175-84

Device Problem Battery Problem (2885)

Patient Problems Bruise/Contusion (1754); Convulsion/Seizure (4406); Swelling/ Edema (4577)

Event Date 07/10/2023

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation.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.A tripped trend review was conducted for the reported complaint and freestyle libre sensors, no trends were identified that would indicate any product related issues.If the product is returned, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A delivery delay with a replacement abbott diabetes care (adc) device was reported.The replacement device was issued due customer reported being unable to test using their blood glucose meter due to a battery icon appearing on the meter display.Due to delivery delay, customer experienced a seizure, "fell on the floor", "two black eyes", "damaged back and neck", "swollen hands", and was unable to self-treat, requiring going to the hospital.At the hospital, a healthcare professional (hcp) provided third-party treatment of unspecified intravenous medication and kept customer for one day before discharge.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE PRECISION NEO
• Type of Device: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 17398401
• MDR Text Key: 319829083
• Report Number: 2954323-2023-31509
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K140371
• 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
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 75175-84
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention