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

Model Number 71181-70

Device Problem Battery Problem (2885)

Patient Problem Insufficient Information (4580)

Event Date 03/14/2022

Event Type  Injury  

Event Description

A healthcare provider reported that the customer obtained a unspecified battery issue of ketones not detected upon attempting to test using the adc device.No symptoms were reported however, the customer self-treated (unspecified) and then had contact with healthcare provider who provided unspecified treatment.No further information was provided.There was no report of death or permanent impairment 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 precision neo h and no trends were identified that would indicate any product related issues.The date the incident occurred is unknown.The date entered is the date abbott diabetes care became aware of the event.The device manufacturing date is unknown.The date entered is the date abbott diabetes care became aware of the event.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 H
• 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: 13934919
• MDR Text Key: 288086393
• Report Number: 2954323-2022-10126
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K153330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71181-70
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2022
• 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