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

Model Number 75175-84

Device Problem Display or Visual Feedback Problem (1184)

Patient Problems Dizziness (2194); Loss of consciousness (2418); Diaphoresis (2452); Convulsion/Seizure (4406)

Event Date 11/12/2022

Event Type  Injury  

Event Description

A customer reported a delivery delay with a replacement adc device.A customer initially reported that their adc device display froze and a replacement device was ordered however, the customer called back to report that they did not receive the device.Consequently, the customer experienced dizziness, sweating, paleness, seizure, and a loss of consciousness, and was unable to self-treat.The customer was seen at a hospital and was administered serum, primperan, and other unknown medications via iv for treatment.No further information was provided.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

At this time product has not yet been returned and a valid serial number has not been provided.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 available tripped trend reports were reviewed for freestyle optium neo meter and dsplght-8 for the last year.The review did not identify any trends that would indicate any product related issues related to this complaint.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.

• 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: 15972120
• MDR Text Key: 305412210
• Report Number: 2954323-2022-45655
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 11/16/2022
• Initial Date FDA Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention