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

Model Number	70805-70
Medical Device Problem Codes	No Device Output (1435); Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	04/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time product has not yet been returned and the serial number provided is not valid.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 strips were reviewed and the dhrs showed the freestyle strips passed all tests prior to release.A tripped trend review was conducted for the reported complaint and freestyle lite meter and no trends were identified that would indicate any product related issues.Retain testing was performed for freestyle strips and all units performed in specification and passed.The exact date that the incident occurred is unknown.The date entered is based on the customer report of "couple days ago".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 or Problem Description
A customer reported the adc blood glucose meter did not give any results after the blood sample was applied to the test strip as it would not advance beyond the ¿apply blood¿ screen.The customer experienced a loss of consciousness and received unspecified third-party medical treatment.No further information was reported.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE LITE
• Common Device Name: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• MDR Report Key: 11815742
• Report Number: 2954323-2021-69084
• Device Sequence Number: 11703957
• Product Code: NBW
• UDI-Device Identifier: 00699073708229
• UDI-Public: 00699073708229
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K092602
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/12/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/28/2023
• Device Model Number: 70805-70
• Device Catalogue Number: 70822
• Device Lot Number: 1146975
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 05/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention