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

Model Number 75175-83

Device Problem Premature Discharge of Battery (1057)

Patient Problem Insufficient Information (4580)

Event Date 04/29/2022

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The date of event 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.

Event Description

A delivery delay with a replacement adc device was reported.The replacement device was issued due to a fast-draining battery, and due to delivery delay, customer was unable to test and required unspecified third-party treatment.No further details were provided as customer declined to troubleshoot further.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned as of this report.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs (device history review) for the freestyle optium neo meter were reviewed and the dhrs showed the freestyle optium neo meter passed all tests prior to release.If the product is returned, the case will be re-opened and a physical investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A delivery delay with a replacement adc device was reported.The replacement device was issued due to a fast-draining battery, and due to delivery delay, customer was unable to test and required unspecified third-party treatment.No further details were provided as customer declined to troubleshoot further.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

The returned meter was investigated.Meter powered on with button depression.Power consumption test was performed using keithley source meter.All results were within specification.Therefore, the complaint was not confirmed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A delivery delay with a replacement adc device was reported.The replacement device was issued due to a fast-draining battery, and due to delivery delay, customer was unable to test and required unspecified third-party treatment.No further details were provided as customer declined to troubleshoot further.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: 14359316
• MDR Text Key: 291405279
• Report Number: 2954323-2022-15158
• 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,Followup,Followup
• Report Date: 09/09/2022

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: 75175-83
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 04/29/2022
• Initial Date FDA Received: 05/11/2022
• Supplement Dates Manufacturer Received: 05/18/2022; 08/31/2022
• Supplement Dates FDA Received: 06/02/2022; 09/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2015
• 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