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

Model Number 75175-84

Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)

Patient Problems Hypoglycemia (1912); Dizziness (2194); Loss of consciousness (2418)

Event Date 08/01/2022

Event Type  Injury  

Manufacturer Narrative

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.Dhrs for the freestyle optium neo meter were reviewed and the dhrs showed the freestyle optium neo meter passed all tests prior to release.A dhr for the precision strips was reviewed and the dhr showed the precision strips passed all tests before release.Retain testing was performed and all units performed within specification.The date the incident occurred is unknown.The date entered is based on the customer's report of "(b)(6) 2022".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 customer initially reported an error message issue with the adc device and being unable to obtain readings.A replacement product was ordered, however due to a delivery delay, the customer was unable to monitor glucose levels and experienced symptoms of dizziness, a loss of consciousness and was unable to self-treat.The customer had contact with a healthcare professional who provided oral sugar as treatment.No further information was provided.There was no report of death or permanent impairment associated with this event.

• 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: 15831241
• MDR Text Key: 303993657
• Report Number: 2954323-2022-42482
• 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: 11/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2022
• 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
• Date Manufacturer Received: 10/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2015
• 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