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

Model Number 75175-83

Device Problems Failure to Power Up (1476); Unable to Obtain Readings (1516)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 11/26/2023

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.Extended investigation involved a manufacturing review (including 5 years of device history records (dhrs)), previous complaint and corrective and preventive action (capa) investigations conducted for blank screen issues, process failure mode effects analyses (pfmeas), design controls, and design failure mode effects analyses (dfmeas), risk management reports, risk evaluations, and label copy.The investigation did not identify any indication that the product did not meet specification.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 battery/no power issue was reported with the adc device.Customer was unable to test due to the device not powering on with button press or test strip insertion and as a result, experienced a loss of consciousness.Customer was unable to self-treat and was treated with jelly babies by a third-party.No further treatment was reported.There was no report of death or permanent impairment associated with this event.

Event Description

A battery/no power issue was reported with the adc device.Customer was unable to test due to the device not powering on with button press or test strip insertion and as a result, experienced a loss of consciousness.Customer was unable to self-treat and was treated with jelly babies by a third-party.No further treatment was reported.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Meter (b)(6) has been returned and investigated with retained batteries.Visual inspection has been performed on returned meter and no issues were observed.Retain batteries were inserted and the indicator lights did not flash.Meter powered on with button depression.Blank screen was not observed.The complaint was not confirmed.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREESTYLE OPTIUM 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: 18288249
• MDR Text Key: 329992741
• Report Number: 2954323-2023-53135
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• 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
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2021
• 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