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

Model Number 75175-84

Device Problems No Device Output (1435); Power Problem (3010)

Patient Problem Hyperglycemia (1905)

Event Date 08/30/2022

Event Type  Injury  

Event Description

A port issue was reported with the adc device.A customer reported that the adc meter powers on when the button is pressed but not when the test strip is inserted.As a result, the customer became hyperglycemic and was unable to obtain readings.The customer had contact with a healthcare professional who obtained unspecified blood glucose and administered fluids and an insulin (type/dose unknown) injection for the diagnosis of hyperglycemia.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.A tripped trend review was conducted for the reported complaint and freestyle optium neo meter and 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.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.

• Brand Name: FREESTYLE NEO OPTIUM
• 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: 15447593
• MDR Text Key: 300162631
• Report Number: 2954323-2022-34585
• 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: 09/19/2022

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
• Device Lot Number: 4500184895
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/31/2022
• Initial Date FDA Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2022
• 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