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

Model Number	70805-70
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Codes	Chest Pain (1776); Hyperglycemia (1905); Dizziness (2194)
Date of Event	10/01/2020
Type of Reportable Event	Serious Injury
Additional 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.The dhrs (device history review) for the freestyle strips were reviewed and the dhrs showed the freestyle strips passed all tests prior to release.The dhrs (device history review) for the freestyle lite meter were reviewed and the dhrs showed the freestyle lite meter passed all tests prior to release.Retain testing was performed 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.The date of event is unknown.The date entered is the date reported as the "first week of (b)(6) 2020." all pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A customer reported low glucose results than how they feel when testing on the adc meter.In (b)(6) 2020, the customer obtained a blood glucose of 83mg/dl and experienced dizziness, shakiness, thirst, and chest pain which she stated meant to her that her blood glucose was high.Emergency services were called and after an unspecified amount of time, the customer was taken to the hospital where unknown blood glucose and blood pressure were obtained and the customer was given an iv and treated with "metformin, aspirin, metoprolol and spironol," which is a new medication for the customer.The customer was diagnosed with hyperglycemia and hospitalized for 3 days.There was no report of death or permanent injury associated with this event.

• Brand Name: FRESTYLE 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: 10752726
• Report Number: 2954323-2020-08921
• Device Sequence Number: 11592573
• Product Code: NBW
• UDI-Device Identifier: 00699073708229
• UDI-Public: 00699073708229
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K092602
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2020

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: 02/28/2022
• Device Model Number: 70805-70
• Device Catalogue Number: 70822
• Device Lot Number: 1115840
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 10/28/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 89