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

Model Number 75175-83

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 07/20/2022

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.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A settings/memory issue was reported with the adc device.A customer reported receiving the ¿same exact readings of 45 mg/dl¿ on their meter and consequently, the customer experienced a loss of consciousness.The customer was treated with grapes, soda, and cookies by a family member.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

This serves as a correction report.The initial previous report was submitted in error.Section b-5 was incorrectly documented.After further review of the case details, the reported sensor reading (33 mg/dl) is indicative of hypoglycemia and consistent with the treatment (glucose) therefore, no submission is required.No further reports will be submitted under mfr 2954323-2022-28606.

Manufacturer Narrative

Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.A valid serial number was not provided for the meter.A tripped trend review was conducted for the reported complaint and the freestyle precision neo meter, no trends were identified that would indicate any product related issues.Dhrs (device history review) for the precision strips was reviewed and the dhrs showed the precision strips passed all tests prior to release.Retain testing was performed for precision strips, and all units performed in specification and passed.If the product is returned, a physical investigation will be performed, and a follow-up report submitted.Note: the device manufacturer date for the reported meter serial number is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.Upon extended investigation, it was determined that the serial number provided by the customer ((b)(6)) and previously reported to the fda was not a valid serial number.

Event Description

A settings/memory issue was reported with the adc device.A customer reported receiving the ¿same exact readings of 33 mg/dl¿ on their meter and consequently, the customer experienced a loss of consciousness.The customer was treated with grapes, soda, and cookies by a family member.There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE NEO PRECISION
• 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: 15210850
• MDR Text Key: 297709282
• Report Number: 2954323-2022-28606
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2023
• Device Model Number: 75175-83
• Device Lot Number: 4500186080
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female